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Instatrak 3500 Plus System
- Starting date:
- November 27, 2012
- Posting date:
- December 24, 2012
- 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-25911
Recalled Products
- Instatrak 3500 Plus System
Reason
The reason the recall was intiated was because several potential safety issues have been identified with the use of the device. The navigation system may lock up or restart unexpectedly. If two scans from the same modality and same patient are transferred to the system, they may combine into one scan, and the transmitter arm movement after registration may result in inaccuracy and users may experience difficulty calibrating the device.
Affected products
A. Instatrak 3500 Plus System
Lot or serial number
N/A
Model or catalog number
1006236-001
Companies
- Manufacturer
- GE OEC Medical Systems Inc.