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DISCOVERY IGS 730/740 SYSTEM (2016-04-18)
- Starting date:
- April 18, 2016
- Posting date:
- May 16, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-58348
Affected products
- DISCOVERY IGS 730 SYSTEM
- DISCOVERY IGS 740
Reason
The following issue is being addressed by GE Healthcare file No. FMI 12246: GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable loss of image acquisition. The affected discovery systems may experience multiple x-ray abort errors during a real-time interventional procedure. This issue could potentially happen before or during a fluoroscopic interventional procedure. There have been no injuries reported as a result of this issue.
Affected products
-
DISCOVERY IGS 730 SYSTEM
Lot or serial number
- 0000HXE9001292
Model or catalog number
- 5418812
Companies
- Manufacturer
-
GE Medical Systems SCS
283 Rue De La Miniere
Buc
B. DISCOVERY IGS 740
Lot or serial number
0000HXED001317
0000HXED001318
0000HXED001320
Model or catalog number
5418813
Companies
- Manufacturer
-
GE Medical Systems SCS
283 Rue De La Miniere
Buc