Allen Medical Bow Frame Recalled Due to Potential Base Cracking
Allen Medical Systems is recalling 161 Bow Frame Model A-70800 surgical platforms because the base may crack when patients are transferred onto the device.
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 recall involves a structural defect in a medical device used during surgery, which poses a significant risk of injury if the frame cracks during patient transfer.
Plain-English summary
Allen Medical Systems is recalling 161 units of the Allen Medical Bow Frame Model A-70800. This surgical platform is used to position patients for lumbar spine procedures. The recall is due to a defect where the base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame.
The affected units were distributed worldwide, including in the United States, Australia, Bangladesh, Brazil, Canada, China, Denmark, France, Germany, Greece, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia, Netherlands, Spain, Switzerland, Taiwan, UAE, and the UK. Specific serial numbers for the affected units are listed in the agency's recall record.
Healthcare facilities and consumers should stop using the affected Bow Frames immediately and contact Allen Medical Systems for instructions on how to proceed with the recall.
The recalled product
- Product
- Allen Medical Bow Frame Model A-70800. Surgical platform used to position patients for lumbar spine procedures.
- Manufacturer
- Allen Medical Systems
- Affected units
- 161
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Allen Medical Systems under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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