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