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GE Medical Systems, LLC Products
- Starting date:
- November 13, 2012
- Posting date:
- January 7, 2013
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public (GP), Healthcare Professionals, Hospitals
- Identification number:
- RA-16507
Recalled Products
A. Avantix Legacy D R/F System
B. AMX 4 Mobile X-Ray System
C. AMX 4+ Mobile X-Ray System
D. Definum AMX 700 Digital Mobile System
E. Precision 500D
F. Brivo XR285AMX X-Ray System
G. Optima XR220AMX X-Ray System
H. Optima XR200AMX X-Ray System
Reason
This recall is due to an update by GE Healthcare on the preventative maintenance and cleaning procedures of the exposure switches, footswitches and hand switches of X-ray systems, to address aggressive disinfectant procedures used by the users. The updates include recommended replacement of console switches every three years and recommends cleaning X-ray systems with a cloth moistened in warm, soapy water or cleaners approved by GE.
Affected products
A. Avantix Legacy D R/F System
Lot or serial number
N/A
Model or catalog number
2258627, S0910JB
Companies
- Manufacturer
- GE Medical Systems, LLC
B. AMX 4 Mobile X-Ray System
Lot or serial number
N/A
Model or catalog number
2115090, 2115090-12, 46-270157G-1, 46-270954G1, 46-329267G1
Companies
- Manufacturer
- GE Medical Systems, LLC
C. AMX 4+ Mobile X-Ray System
Lot or serial number
N/A
Model or catalog number
2169360-7, 2236420-7, 2275938-7
Companies
- Manufacturer
- GE Medical Systems, LLC
D. Definum AMX 700 Digital Mobile System
Lot or serial number
N/A
Model or catalog number
S2000PA/PB
Companies
- Manufacturer
- GE Medical Systems, LLC
E. Precision 500D
Lot or serial number
N/A
Model or catalog number
2403791, 2407576
Companies
- Manufacturer
- GE Medical Systems, LLC
F. Brivo XR285AMX X-Ray System
Lot or serial number
N/A
Model or catalog number
5555000, 5555000-2
Companies
- Manufacturer
- GE Medical Systems, LLC
G. Optima XR220AMX X-Ray System
Lot or serial number
N/A
Model or catalog number
5555000-5, 5555000-6
Companies
- Manufacturer
- GE Medical Systems, LLC
H. Optima XR200AMX X-Ray System
Lot or serial number
N/A
Model or catalog number
5555000-3, 5555000-4
Companies
- Manufacturer
- GE Medical Systems, LLC