Class IIOngoing
QUANTUM OPS Inc recalls Brand Name: ADAPTABLE Beach Chair Product Name: Beach Chair surgical patient positioner Model/Catalog Number:
Recall date · record updated Oct 14, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)
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.
- Company
- QUANTUM OPS Inc
- 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).
- Who’s affected
- U.S. Nationwide distribution in the states of CA and TX.
- Where
- Nationwide
- Official notice
- www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99384…
Products
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.
Codes/lots: 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:Quantity: 266Recall no. Z-0076-2027Class II
Update history
- First listed on OVERLOOKED from the official record.
When the agency expands or changes this recall, we update this page and log the change here.
Proof: raw official record (JSON) · fetched from FDA API
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