Health product recall

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