Optima NM/CT 640 Unit, Discovery NM/CT (670 CZT, 670 ES), Discovery 670 DR, NM/CT (870 DR, 870 CZT), NM 830 (2019-03-19)
- Starting date:
- March 19, 2019
- Posting date:
- April 12, 2019
- 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-69540
Last updated: 2019-04-12
Affected Products
- Optima NM/CT 640 Unit
- Discovery NM/CT 670 CZT
- Discovery NM/CT 670 ES
- Discovery 670 DR
- NM/CT 870 DR
- NM/CT 870 CZT
- NM 830
Reason
During installation of certain nuclear medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector mounting design redundancy. Multiple other design redundancies are in place to ensure the detector mounting remains secure. As a result, it is highly improbable that the detector would become unsecure if the screws loosen. In the unlikely event that the screws loosen and the multiple other detector mounting design redundancies fail, the detector could fall during use and lead to potentially life-threatening bodily harm. No detector falls have been reported as a result of this issue.
Affected products
-
Optima NM/CT 640 Unit
Lot or serial number
ONMX26480
ONMX26502
Model or catalog number
H3100YD
Companies
- Manufacturer
-
GE Medical Systems Israel, Functional Imaging
4 Hayozma Street
Tirat Hacarmel
0030200
ISRAEL
B. Discovery NM/CT 670 CZT
Lot or serial number
AD7X38019
Model or catalog number
H3906CU
Companies
- Manufacturer
-
GE Medical Systems Israel, Functional Imaging
4 Hayozma Street
Tirat Hacarmel
0030200
ISRAEL
C. Discovery NM/CT 670 ES
Lot or serial number
ESDX35020
Model or catalog number
H3100BK
Companies
- Manufacturer
-
GE Medical Systems Israel, Functional Imaging
4 Hayozma Street
Tirat Hacarmel
0030200
ISRAEL
D. Discovery 670 DR
Lot or serial number
DRGX56004
Model or catalog number
H3100AL
Companies
- Manufacturer
-
GE Medical Systems Israel, Functional Imaging
4 Hayozma Street
Tirat Hacarmel
0030200
ISRAEL
E. NM/CT 870 DR
Lot or serial number
870Y64034
Model or catalog number
H3100AR
Companies
- Manufacturer
-
GE Medical Systems Israel, Functional Imaging
4 Hayozma Street
Tirat Hacarmel
0030200
ISRAEL
F. NM/CT 870 CZT
Lot or serial number
87CX63015
Model or catalog number
H3906CV
Companies
- Manufacturer
-
GE Medical Systems Israel, Functional Imaging
4 Hayozma Street
Tirat Hacarmel
0030200
ISRAEL
G. NM 830
Lot or serial number
830X60022
Model or catalog number
H3910AB
Companies
- Manufacturer
-
GE Medical Systems Israel, Functional Imaging
4 Hayozma Street
Tirat Hacarmel
0030200
ISRAEL