{"recall":{"id":"fda-device-99828","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Mindray DS USA, Inc. recalls 8 products","firm":"Mindray DS USA, Inc.","date":"2026-08-31","reported":"2026-10-14","status":"Ongoing","classification":"Class III","products":[{"name":"ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A","code":"Part numbers of ePM Series Patient Monitors Operator's Manuals: 1. Guardian Plus Operator's Manual (OEM, MDPro) up to and including revision 4.0; Part No. 046-026408-00 2. ePM 10A Operator's Manual up to and including revision 12.0; Part No. 046-019796-00 3. ePM 12MA Operator's Manual up to and including revision 13.0; Part No. 046-019797-00 4. ePM 10M, ePM 12M Operator's Manual up to and including revision 13.0; Part No. 046-019798-00 5. ePM 15M Operator's Manual up to and including revision 3.0; Part No. 046-028915-00","quantity":"32,184 units","number":"Z-0109-2027","classification":"Class III"},{"name":"BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/N22.","code":"Part numbers of BeneVision N1 and N-Series Patient Monitors Operator's Manuals: 1. BeneVision N1 Operator's Manual up to and including revision 21.0; Part No. 046-011405-00. 2. BeneVision N-Series Operator's Manual up to and including revision 23; Part No. 046-011259-0.","quantity":"44,651 units","number":"Z-0110-2027","classification":"Class III"},{"name":"BeneVision Series Telemetry Monitor. Operator's Manuals: TM70/TM80","code":"Part numbers of BeneVision Series Telemetry Monitor Operator's Manuals: 1. BeneVision TMS60 (TD60)/TM80 (no alarms) Operator's Manual up to and including revision 5.0; Part No. 046-011232-00 2. BeneVision TM70 Telemetry Monitor Operator's Manual up to and including revision 4.0; Part No. 046-019362-00 3. TM80 Telemetry Monitor Operator's Manual up to and including revision 9.0; Part No. 046-012662-00 4. TMS60 Telemetry Monitoring System Operator's Manual up to and including revision 4.0; Part No. 046-007056-00","quantity":"29,737 units","number":"Z-0111-2027","classification":"Class III"},{"name":"Panorama and Telemetry Monitoring System. Operator's Manuals: TMS-6016/Panorama Telepack-608/TMS60 (TD60).","code":"Part Numbers of the Panorama and Telemetry Monitoring System Operator's Manuals: 1. Panorama Telepack-608 Telemetry Monitoring System Operator's Manual up to and including revision 1.0; Part No. 046-007526-00 2. TMS-6016 Operator's Manual up to and including revision 11.0; Part No. 046-005012-00","quantity":"11,831 units","number":"Z-0112-2027","classification":"Class III"},{"name":"BeneView Series. Operator's Manuals: T5 / T8","code":"Part Numbers of the BeneView Series Operator's Manuals: 1. BeneView T5 Operator's Manual up to and including revision 17.0; Part No. 6802-20-66856 2. BeneView T8 Operator's Manual up to and including revision 16.0; Part No. 6800-20-50710","quantity":"133 units","number":"Z-0113-2027","classification":"Class III"},{"name":"Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V","code":"Part Numbers of Passport Series Patient Monitor Operator's Manuals: 1. Passport 8_12 Operator's Manual up to and including revision 13.0; Part No. 046-004417-00 2. Passport 17M 12M Operator's Manual up to and including revision 17.0; Part No. 046-005013-00 3. Passport V Patient Monitors Operating Instructions up to and including revision 10.0; Part No. 0070-00-0704-02","quantity":"39,891 units","number":"Z-0114-2027","classification":"Class III"},{"name":"cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12","code":"Part Numbers of the cPM Series Patient Monitor Operator's Manual: 1. cPM 12/cPM 8 Operator's Manual up to and including revision 4.0; Part No. 046-011732-00","quantity":"1,699 units","number":"Z-0115-2027","classification":"Class III"},{"name":"T1 Patient Monitor. Operator's Manual: T1 Patient Monitor","code":"T1 Patient Monitor Operator's Manual: 1. T1 Operator's Manual up to and including revision 14.0; Part No. 046-006734-00","quantity":"4,946 units","number":"Z-0116-2027","classification":"Class III"}],"reason":"Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions","hazard":"FDA Class III: not likely to cause adverse health consequences (FDA definition).","affected":"Worldwide - Nationwide and the country of Canada.","nationwide":true,"states":[],"units":"32,184 units; 44,651 units; 29,737 units; 11,831 units; 133 units; 39,891 units; 1,699 units; 4,946 units","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99828","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"2eedf108acd325ae","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99828","record":[{"status":"Ongoing","city":"Mahwah","state":"NJ","country":"United States","classification":"Class III","openfda":{},"product_type":"Devices","event_id":"99828","recalling_firm":"Mindray DS USA, Inc.","address_1":"800 Macarthur Blvd","address_2":"N/A","postal_code":"07430-2001","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - Nationwide and the country of Canada.","recall_number":"Z-0109-2027","product_description":"ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A","product_quantity":"32,184 units","reason_for_recall":"Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions","recall_initiation_date":"20260831","center_classification_date":"20261007","report_date":"20261014","code_info":"Part numbers of ePM Series Patient Monitors Operator's Manuals: 1. Guardian Plus Operator's Manual (OEM, MDPro) up to and including revision 4.0; Part No. 046-026408-00  2. ePM 10A Operator's Manual up to and including revision 12.0; Part No. 046-019796-00  3.  ePM 12MA Operator's Manual up to and including revision 13.0; Part No. 046-019797-00  4.  ePM 10M, ePM 12M Operator's Manual up to and including revision 13.0; Part No. 046-019798-00  5.  ePM 15M Operator's Manual up to and including revision 3.0; Part No. 046-028915-00"},{"status":"Ongoing","city":"Mahwah","state":"NJ","country":"United States","classification":"Class III","openfda":{},"product_type":"Devices","event_id":"99828","recalling_firm":"Mindray DS USA, Inc.","address_1":"800 Macarthur Blvd","address_2":"N/A","postal_code":"07430-2001","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - Nationwide and the country of Canada.","recall_number":"Z-0110-2027","product_description":"BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/N22.","product_quantity":"44,651 units","reason_for_recall":"Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions","recall_initiation_date":"20260831","center_classification_date":"20261007","report_date":"20261014","code_info":"Part numbers of BeneVision N1 and N-Series Patient Monitors Operator's Manuals: 1. BeneVision N1 Operator's Manual up to and including revision 21.0; Part No. 046-011405-00.  2. BeneVision N-Series Operator's Manual up to and including revision 23; Part No. 046-011259-0."},{"status":"Ongoing","city":"Mahwah","state":"NJ","country":"United States","classification":"Class III","openfda":{},"product_type":"Devices","event_id":"99828","recalling_firm":"Mindray DS USA, Inc.","address_1":"800 Macarthur Blvd","address_2":"N/A","postal_code":"07430-2001","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - Nationwide and the country of Canada.","recall_number":"Z-0111-2027","product_description":"BeneVision Series Telemetry Monitor. Operator's Manuals: TM70/TM80","product_quantity":"29,737 units","reason_for_recall":"Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions","recall_initiation_date":"20260831","center_classification_date":"20261007","report_date":"20261014","code_info":"Part numbers of BeneVision Series Telemetry Monitor Operator's Manuals: 1. BeneVision TMS60 (TD60)/TM80 (no alarms) Operator's Manual up to and including revision 5.0; Part No. 046-011232-00   2. BeneVision TM70 Telemetry Monitor Operator's Manual up to and including revision 4.0; Part No. 046-019362-00   3. TM80 Telemetry Monitor Operator's Manual up to and including revision 9.0; Part No. 046-012662-00   4. TMS60 Telemetry Monitoring System Operator's Manual up to and including revision 4.0; Part No. 046-007056-00"},{"status":"Ongoing","city":"Mahwah","state":"NJ","country":"United States","classification":"Class III","openfda":{},"product_type":"Devices","event_id":"99828","recalling_firm":"Mindray DS USA, Inc.","address_1":"800 Macarthur Blvd","address_2":"N/A","postal_code":"07430-2001","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - Nationwide and the country of Canada.","recall_number":"Z-0112-2027","product_description":"Panorama and Telemetry Monitoring System. Operator's Manuals: TMS-6016/Panorama Telepack-608/TMS60 (TD60).","product_quantity":"11,831 units","reason_for_recall":"Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions","recall_initiation_date":"20260831","center_classification_date":"20261007","report_date":"20261014","code_info":"Part Numbers of the Panorama and Telemetry Monitoring System Operator's Manuals: 1. Panorama Telepack-608 Telemetry Monitoring System Operator's Manual up to and including revision 1.0; Part No. 046-007526-00  2. TMS-6016 Operator's Manual up to and including revision 11.0; Part No. 046-005012-00"},{"status":"Ongoing","city":"Mahwah","state":"NJ","country":"United States","classification":"Class III","openfda":{},"product_type":"Devices","event_id":"99828","recalling_firm":"Mindray DS USA, Inc.","address_1":"800 Macarthur Blvd","address_2":"N/A","postal_code":"07430-2001","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - Nationwide and the country of Canada.","recall_number":"Z-0113-2027","product_description":"BeneView Series. Operator's Manuals: T5 / T8","product_quantity":"133 units","reason_for_recall":"Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions","recall_initiation_date":"20260831","center_classification_date":"20261007","report_date":"20261014","code_info":"Part Numbers of the BeneView Series Operator's Manuals: 1. BeneView T5 Operator's Manual up to and including revision 17.0; Part No. 6802-20-66856  2. BeneView T8 Operator's Manual up to and including revision 16.0; Part No. 6800-20-50710"},{"status":"Ongoing","city":"Mahwah","state":"NJ","country":"United States","classification":"Class III","openfda":{},"product_type":"Devices","event_id":"99828","recalling_firm":"Mindray DS USA, Inc.","address_1":"800 Macarthur Blvd","address_2":"N/A","postal_code":"07430-2001","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - Nationwide and the country of Canada.","recall_number":"Z-0114-2027","product_description":"Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V","product_quantity":"39,891 units","reason_for_recall":"Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions","recall_initiation_date":"20260831","center_classification_date":"20261007","report_date":"20261014","code_info":"Part Numbers of Passport Series Patient Monitor Operator's Manuals: 1. Passport 8_12 Operator's Manual up to and including revision 13.0; Part No. 046-004417-00   2. Passport 17M 12M Operator's Manual up to and including revision 17.0; Part No. 046-005013-00  3. Passport V Patient Monitors Operating Instructions up to and including revision 10.0; Part No. 0070-00-0704-02"},{"status":"Ongoing","city":"Mahwah","state":"NJ","country":"United States","classification":"Class III","openfda":{},"product_type":"Devices","event_id":"99828","recalling_firm":"Mindray DS USA, Inc.","address_1":"800 Macarthur Blvd","address_2":"N/A","postal_code":"07430-2001","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - Nationwide and the country of Canada.","recall_number":"Z-0115-2027","product_description":"cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12","product_quantity":"1,699 units","reason_for_recall":"Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions","recall_initiation_date":"20260831","center_classification_date":"20261007","report_date":"20261014","code_info":"Part Numbers of the cPM Series Patient Monitor Operator's Manual: 1. cPM 12/cPM 8 Operator's Manual up to and including revision 4.0; Part No. 046-011732-00"},{"status":"Ongoing","city":"Mahwah","state":"NJ","country":"United States","classification":"Class III","openfda":{},"product_type":"Devices","event_id":"99828","recalling_firm":"Mindray DS USA, Inc.","address_1":"800 Macarthur Blvd","address_2":"N/A","postal_code":"07430-2001","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - Nationwide and the country of Canada.","recall_number":"Z-0116-2027","product_description":"T1 Patient Monitor. Operator's Manual: T1 Patient Monitor","product_quantity":"4,946 units","reason_for_recall":"Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions","recall_initiation_date":"20260831","center_classification_date":"20261007","report_date":"20261014","code_info":"T1 Patient Monitor Operator's Manual:  1. T1 Operator's Manual up to and including revision 14.0; Part No. 046-006734-00"}]}}