Allen Medical Systems Recalls F-T3SYSTEM Surgical Table Accessories
Allen Medical Systems is recalling 83 F-T3SYSTEM surgical table accessories because rail section clamps may fail during use, posing a risk of critical harm to patients.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that the defect 'could result in critical harm to the patient,' which aligns with the rubric criteria for Severe (4) involving significant injury reports or high-risk structural defects.
Plain-English summary
Allen Medical Systems is recalling 83 units of the F-T3SYSTEM, T3 (Trumpf Table Top) System. This device is a surgical table accessory used to allow prone positioning on operating room table tops during spinal surgery. The system includes a table top frame and arm supports.
The recall was initiated because the firm became aware that the rail section clamps used to attach the leg support of the device may fail during use. This potential failure could result in critical harm to the patient.
The affected units were distributed nationwide in the United States and to Australia, France, Saudi Arabia, and Germany. Users should stop using the affected devices and contact Allen Medical Systems for further instructions.
The recalled product
- Product
- F-T3SYSTEM, T3 (Trumpf Table Top) System The device is a surgical table accessory system used to allow prone positioning on OR table tops during spinal surgery. The system consists of a table top frame, arm supports,
- Manufacturer
- Allen Medical Systems
- Affected units
- 83
Distribution
Distributed nationwide across the United States.
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