FDA-Device2018-02-28Class II

Allen Medical Bow Frame Model A-70800. Surgical platform used to position patients for lumbar spine procedures.

Allen Medical Systems
Hazard

The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame.

Sold states
Worldwide distribution. US Nationwide, Australia, Bangladesh, Brazil, Canada, China, Denmark, France, Germany, Greece, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia, Netherlands, Spain, Switzerland, Taiwan, UAE, and UK.
Affected count
161 units total
Manufactured in
100 Discovery Way, N/A, Acton, MA, United States
Products
Allen Medical Bow Frame Model A-70800. Surgical platform used to position patients for lumbar spine procedures.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0641-2018

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