FDA-Device2026-10-14Class IIPROCESSING DEFECT
QUANTUM OPS ADAPTABLE Beach Chair surgical positioner recalled for inadequate weld in head support
What this means
QUANTUM OPS ADAPTABLE Beach Chair surgical positioners contain an inadequate weld in the patient head positioning system (BC-0105 subcomponent). This manufacturing defect could potentially affect the stability and safety of the device during surgical procedures. The defect was identified in specific lot numbers distributed in California and Texas.
- Check your device's product number (804-33-300 or 3105-400-030) and lot number against the affected lots listed in the recall notice.
- Do not use affected units until you receive corrective instructions from the manufacturer.
- Contact QUANTUM OPS or your Stryker/Enovis representative immediately if your device matches the affected serial numbers.
The agency's original wording
Hazard
Due to a manufacturing issue (inadequate weld) for patient head positioning system.
Intended for
Adults
Illnesses reported
None reported
Sold states
U.S. Nationwide distribution in the states of CA and TX.
Affected count
266
Manufactured in
2001 N Chamberlain Ave, N/A, Chattanooga, TN, United States
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0076-2027Want us to check the next one for you?
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