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O-ARM O2 IMAGING SYSTEM (2017-10-27)
- Starting date:
- October 27, 2017
- Posting date:
- November 10, 2017
- 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-65088
Affected products
O-ARM O2 IMAGING SYSTEM
Reason
During servicing of certain internal components of the O-arm O2, it is possible that the high-power cable connector may come in contact with surrounding metal (toggle switch or corner of battery tray) during the disconnecting/reconnecting process. If this occurs, it may result in an electrical short and a shock to the field service technician.
Affected products
O-ARM O2 IMAGING SYSTEM
Lot or serial number
All lots
Model or catalog number
BI-700-02000
Companies
- Manufacturer
-
Medtronic Navigation, Inc. (Littleton)
300 Foster Street
Littleton
01460
Massachusetts
UNITED STATES