Quantum Ops Recalls ADAPTABLE Beach Chair Surgical Patient Positioners
Quantum Ops Inc is recalling 266 ADAPTABLE Beach Chair surgical patient positioners due to a manufacturing issue involving inadequate welds in the patient head positioning system.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as Class II due to a manufacturing issue involving an inadequate weld in the patient head positioning system. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Quantum Ops Inc is recalling 266 units of the ADAPTABLE Beach Chair surgical patient positioner. The recall covers specific model and catalog numbers, including 804-33-300 (Enovis) and 3105-400-030 (Stryker), as well as internal designations BC-0001 and BC-0220. The affected devices are finished surgical positioners that mount to the accessory rails of the operating room table leg section to elevate and support a patient's upper body in an upright position during procedures.
The recall is being conducted due to a manufacturing issue identified in the patient head positioning system, specifically an inadequate weld in the BC-0105 subcomponent. The source text does not report any illnesses, injuries, or deaths associated with this defect.
The affected units were distributed nationwide in the United States, specifically in the states of California and Texas. The recall includes specific lot numbers and serial numbers ranging from A-001 to C-172, with certain demonstration or undelivered units excluded. Users of these devices should contact the recalling firm for instructions on how to proceed.
The recalled product
- Product
- 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…
- Manufacturer
- QUANTUM OPS Inc
- Hazard
- Affected units
- 266
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- A-009
- A-013
- A-022
- A-025
- A-0137.
Distribution
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