The Recall Desk
SevereFDA (Devices)·Z-1262-2018·Announced 2018-04-04

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.

What this means for you

Illness, injury, or structural failure has been reported. 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
Category
Medical Device — Surgical Table Accessory
Hazard
Affected units
83

Distribution

Distributed nationwide across the United States.

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