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O-ARM 1000 IMAGING SYSTEM - BASE OARM (2016-07-19)
- Starting date:
- July 19, 2016
- Posting date:
- August 10, 2016
- 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-59746
Affected products
A. O-ARM 1000 IMAGING SYSTEM - BASE OARM
Reason
The recall is to address labeling compliance gaps for the O-Arm 1000, service manual and instructions for use. Manufacturers of x-ray equipment are required to provide information to the user covering aspects of safety, maintenance, and performance. The current O1 instructions for use and the O-Arm general and advanced service manuals are out of compliance with these requirements. To bring the affected O-Arm systems into compliance, manufacturer is providing an errata sheet with the correct information.
Affected products
A. O-ARM 1000 IMAGING SYSTEM - BASE OARM
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- BI-700-00027120
Companies
- Manufacturer
-
Medtronic Navigation, Inc. (Littleton)
300 Foster Street
Littleton
01460
Massachusetts
UNITED STATES