This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
Optima MR360 - Main Unit (2015-03-02)
- Starting date:
- March 2, 2015
- Posting date:
- March 20, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-52605
Recalled Products
A) Optima MR360 - Main Unit
Reason
The latest on-site software version may not have been reinstalled at some sites after service activities were performed that required software to be reloaded. The most recently deployed on-site software version may include safety updates.
Affected products
A) Optima MR360 - Main Unit
Lot or serial number
450670MR2
AM12O9T240
AM12O9T294
Model or catalog number
5312366 (M50002BB)
Companies
- Manufacturer
-
GE Hangwei Medical Systems Co. Ltd.
No. 2 North Yong Chang Street, Beijing Economic, Technological Development Zone,
Beijing
100176
CHINA