Allen Bow Frame, A-70800 (2017-10-27)
- Starting date:
- October 27, 2017
- Posting date:
- April 24, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-66522
Affected products
Allen Bow Frame, A-70800
Reason
A Bow Frame (A-70800) developed cracks in the base during setup. Specifically, as the patient was being positioned on the Bow frame prior to surgery, the operating room staff heard an audible "crack" and observed that the frame had broken. The patient was removed from the Bow Frame without further and surgery was continued utilizing other Operating Room resources/equipment.
Affected products
Allen Bow Frame, A-70800
Lot or serial number
- A413536
Model or catalog number
- A-70800
Companies
- Manufacturer
-
Allen Medical Systems Inc.
100 Discovery Way
Acton
01720
Massachusetts
UNITED STATES