{"recall":{"id":"fda-device-99384","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"QUANTUM OPS Inc recalls Brand Name: ADAPTABLE Beach Chair Product Name: Beach Chair surgical patient positioner Model/Catalog Number: ","firm":"QUANTUM OPS Inc","date":"2026-07-24","reported":"2026-10-14","status":"Ongoing","classification":"Class II","products":[{"name":"Brand Name: ADAPTABLE Beach Chair Product Name: Beach Chair surgical patient positioner Model/Catalog Number: 804-33-300 (Enovis); 3105-400-030 (Stryker); internal BC-0001 / BC-0220 Software Version: N/A Product Description: Surgical beach-chair positioner that mounts to the accessory rails of the OR table leg section to elevate and support the patient's upper body in the upright (beach chair) position during surgical procedures. Component: No, finished device. The failure is in the BC-0105, subcomponent.","code":"Lot Code: GTIN / UDI-DI: 00190446667278 Affected lots / serials: Product Number: 3105-400-030 Lots: 2021110101 Serial Numbers: A-026 A-027 A-028 A-029 A-030 A-031 A-032 A-033 A-034 A-035 A-036 A-037 A-038 A-039 A-040 Lot Number: 2021120201 Serial Numbers: A-041 A-042 A-043 A-044 A-045 A-046 A-047 A-048 A-049 A-050 A-051 A-052 A-053 A-054 A-056 A-057 A-058 A-059 A-060 A-061 A-062 A-063 A-064 A-065 A-066 A-067 A-068 A-069 A-070 Lot Number: 2022010601 Serial Numbers: A-071 A-072 A-073 A-074 A-075 A-076 A-077 A-078 A-079 A-082 A-083 A-084 A-087 A-090 A-091 A-092 A-093 A-094 A-095 A-099 Lot Number: 2023012501 Serial Numbers: C-051 C-052 C-053 C-054 C-055 C-056 C-057 C-058 C-059 C-060 C-061 C-062 C-063 C-064 C-065 C-066 C-067 Lot Number: 2023020201 Serial Numbers: C-001 C-002 C-003 C-004 C-005 C-006 C-007 C-008 C-009 C-010 C-011 C-012 C-013 C-014 C-015 C-016 C-017 C-018 C-019 C-020 C-021 C-022 C-023 C-024 C-025 C-026 C-027 C-028 C-029 C-030 C-031 Lot Number: 2023060101 Serial Numbers: C-081 C-082 C-083 C-084 C-085 C-086 C-087 C-088 C-089 C-090 C-091 C-092 C-093 C-094 C-095 Lot Number: 2023071801 Serial Numbers: C-096 C-097 C-098 C-099 C-100 C-101 C-102 C-103 C-104 C-105 C-106 C-107 C-108 C-109 C-110 C-111 C-112 C-113 C-114 C-115 C-116 C-117 C-118 C-119 C-120 C-121 C-122 Lot Number: 2024081401 Serial Numbers: C-123 C-124 C-125 C-126 C-127 C-128 C-129 C-130 C-131 C-132 Lot Number: 2024091001 Serial Numbers: C-133 C-134 C-135 C-136 C-137 C-138 C-139 C-140 C-141 C-142 C-143 C-144 C-145 C-146 C-147 Lot Number: 2024100301 Serial Numbers: C-148 C-149 C-150 C-151 C-152 C-153 C-154 C-155 C-156 C-157 Lot Number: 2024110401 Serial Numbers: C-158 C-159 C-160 C-161 C-162 C-163 C-164 C-165 C-166 C-167 C-168 C-169 C-170 C-171 C-172 Product Number: 804-33-300 Lot Number: 2020102701 Serial Numbers: A-001 A-002 A-003 A-004 A-005 A-006 A-007 A-010 A-011 A-012 Lot Number: 2021050601 Serial Numbers: A-014 A-015 A-016 A-017 A-018 A-019 A-020 A-021 A-023 A-024 Lot Number: 2022031701 Serial Numbers: A-0131 A-0132 A-0133 A-0134 A-0135 A-0136 A-0138 A-0139 A-0140 Lot Number: 2023020101 Serial Numbers: C-068 C-069 C-070 C-073 C-071 C-072 C-074 C-075 C-076 C-077 C-078 C-079 C-080 Lot Number: 2023032001 Serial Numbers: C-032 C-033 C-034 C-035 C-036 C-037 C-038 C-039 C-040 C-041 C-042 C-043 C-044 C-045 C-046 C-047 C-048 C-049 C-050 2020101201. Excluded (demo/undelivered): A-008, A-009, A-013, A-022, A-025, A-0137.","quantity":"266","number":"Z-0076-2027","classification":"Class II"}],"reason":"Due to a manufacturing issue (inadequate weld) for patient head positioning system.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"U.S. Nationwide distribution in the states of CA and TX.","nationwide":true,"states":[],"units":"266","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=99384","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"a56c453fefffe510","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=99384","record":[{"status":"Ongoing","city":"Chattanooga","state":"TN","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99384","recalling_firm":"QUANTUM OPS Inc","address_1":"2001 N Chamberlain Ave","address_2":"N/A","postal_code":"37406-3808","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"U.S. Nationwide distribution in the states of CA and TX.","recall_number":"Z-0076-2027","product_description":"Brand Name: ADAPTABLE Beach Chair  Product Name: Beach Chair   surgical patient positioner  Model/Catalog Number: 804-33-300 (Enovis); 3105-400-030 (Stryker); internal BC-0001 / BC-0220  Software Version: N/A  Product Description: Surgical beach-chair positioner that mounts to the accessory rails of the OR table leg section to elevate and support the patient's upper body in the upright (beach chair) position during surgical procedures.  Component: No, finished device. The failure is in the BC-0105, subcomponent.","product_quantity":"266","reason_for_recall":"Due to a manufacturing issue (inadequate weld) for patient head positioning system.","recall_initiation_date":"20260724","center_classification_date":"20261002","report_date":"20261014","code_info":"Lot Code: GTIN / UDI-DI: 00190446667278  Affected lots / serials: Product Number: 3105-400-030 Lots: 2021110101 Serial Numbers: A-026 A-027 A-028 A-029 A-030 A-031 A-032 A-033 A-034 A-035 A-036 A-037 A-038 A-039 A-040  Lot Number: 2021120201 Serial Numbers: A-041 A-042 A-043 A-044 A-045 A-046 A-047 A-048 A-049 A-050 A-051 A-052 A-053 A-054 A-056 A-057 A-058 A-059 A-060 A-061 A-062 A-063 A-064 A-065 A-066 A-067 A-068 A-069 A-070  Lot Number: 2022010601 Serial Numbers: A-071 A-072 A-073 A-074 A-075 A-076 A-077 A-078 A-079 A-082 A-083 A-084 A-087 A-090 A-091 A-092 A-093 A-094 A-095 A-099  Lot Number: 2023012501 Serial Numbers: C-051 C-052 C-053 C-054 C-055 C-056 C-057 C-058 C-059 C-060 C-061 C-062 C-063 C-064 C-065 C-066 C-067  Lot Number: 2023020201 Serial Numbers: C-001 C-002 C-003 C-004 C-005 C-006 C-007 C-008 C-009 C-010 C-011 C-012 C-013 C-014 C-015 C-016 C-017 C-018 C-019 C-020 C-021 C-022 C-023 C-024 C-025 C-026 C-027 C-028 C-029 C-030 C-031  Lot Number: 2023060101 Serial Numbers: C-081 C-082 C-083 C-084 C-085 C-086 C-087 C-088 C-089 C-090 C-091 C-092 C-093 C-094 C-095  Lot Number: 2023071801 Serial Numbers: C-096 C-097 C-098 C-099 C-100 C-101 C-102 C-103 C-104 C-105 C-106 C-107 C-108 C-109 C-110 C-111 C-112 C-113 C-114 C-115 C-116 C-117 C-118 C-119 C-120 C-121 C-122  Lot Number: 2024081401 Serial Numbers: C-123 C-124 C-125 C-126 C-127 C-128 C-129 C-130 C-131 C-132  Lot Number: 2024091001 Serial Numbers: C-133 C-134 C-135 C-136 C-137 C-138 C-139 C-140 C-141 C-142 C-143 C-144 C-145 C-146 C-147  Lot Number: 2024100301 Serial Numbers: C-148 C-149 C-150 C-151 C-152 C-153 C-154 C-155 C-156 C-157  Lot Number: 2024110401 Serial Numbers: C-158 C-159 C-160 C-161 C-162 C-163 C-164 C-165 C-166 C-167 C-168 C-169 C-170 C-171 C-172  Product Number: 804-33-300 Lot Number: 2020102701 Serial Numbers: A-001 A-002 A-003 A-004 A-005 A-006 A-007 A-010 A-011 A-012  Lot Number: 2021050601 Serial Numbers: A-014 A-015 A-016 A-017 A-018 A-019 A-020 A-021 A-023 A-024  Lot Number: 2022031701 Serial Numbers: A-0131 A-0132 A-0133 A-0134 A-0135 A-0136 A-0138 A-0139 A-0140  Lot Number: 2023020101 Serial Numbers: C-068 C-069 C-070 C-073 C-071 C-072 C-074 C-075 C-076 C-077 C-078 C-079 C-080  Lot Number: 2023032001 Serial Numbers: C-032 C-033 C-034 C-035 C-036 C-037 C-038 C-039 C-040 C-041 C-042 C-043 C-044 C-045 C-046 C-047 C-048 C-049 C-050  2020101201.  Excluded (demo/undelivered): A-008, A-009, A-013, A-022, A-025, A-0137."}]}}