Health product recall

NM (2020-12-10)

Starting date:
December 10, 2020
Posting date:
December 24, 2020
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-74651



Last updated:
2020-12-24

Affected Products 

A. NM/CT 870 DR

B. NM 830

Reason

Rotor bearing screws were found loose on one detector, leading to the release of one of the four rotor bearings in the detector. In the unlikely event that the screws loosen, and multiple other design redundancies also fail, the detector could fall and lead to potentially life-threatening bodily harm. 

Affected products

A. NM/CT 870 DR

Lot or serial number

870Y64085

Model or catalog number

H3100AR

Companies
Manufacturer

GE Medical Systems Israel

Functional Imaging

4 Hayozma Street

Tirat Hacarmel

0030200

ISRAEL


B. NM 830

Lot or serial number

830Y60095

830Y60119

830Z60193

Model or catalog number

H3910AB

Companies
Manufacturer

GE Medical Systems Israel,

Functional Imaging

4 Hayozma Street

Tirat Hacarmel

0030200

ISRAEL