DISCOVERY 670 DR & NM/CT 870 CZT & NM 830 (2020-08-14)

Starting date:

August 14, 2020

Posting date:

August 28, 2020

Type of communication:

Medical Device Recall

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-73801

Last updated:
2020-08-28

• 
  Reason
• 
  Affected products

Affected Products

1. DISCOVERY 670 DR
2. NM/CT 870 CZT
3. NM 830

Reason

GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector. As a result of multiple other design redundancies the detector remained secured. As a result of these design redundancies, it is highly improbable that the detector would become unsecure if the bearing screws loosen. In the unlikely event that the bearing screws loosen, and the multiple other design redundancies also fail, the detector could fall during use and lead to potentially life-threatening bodily harm. There have been no reported detector falls or injuries as a result of this issue.

Affected products