Brivo MR355, Optima MR360 Product Usage: The Brivo MR355/Optima MR360 is a whole body magnetic resonance scanner designe
FDA device recall Z-3021-2017 · posted 2017-08-02 · Terminated
Recall details
- Recalling firm
- GE Medical Systems, LLC
- Reason for recall
- Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
- Action taken
- Consignees received a written recall notice dated 05/17/2017 notifying them of a correction to all units using an Uninterruptable Power Supply. Consignees were instructed not to unplug the unit and to continue normal use. Units with the Eaton 9130 Uninterruptable Power Supply connected to the MR operator console would receive a correction at no charge. This would involve possibly replacing the power cable. GE Representatives will be contacting consignees to arrange corrections. Any questions can be directed to GE Healthcare Service at 1-800-437-1171 or your local service representative.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 68 units in total
- Distribution
- US Nationwide in the states of : AK, CA, CO, CT, DE, FL, IA, IL, IN, KS, KY, LA, MD, MO, ND, NE, NJ, NY, OH, PA, TX, WA, and WI
- Date initiated
- 2017-05-11
- Date posted
- 2017-08-02
- Date terminated
- 2020-09-09
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BRIVO MR355, OPTIMA MR360 (K123417) | Ge Hangwei Medical Systems Co., Ltd. | 2013-01-17 |
| BRIVO MR355 (K120778) | Ge Hangwei Medical Systems Co., Ltd. | 2012-03-27 |
| BRIVO MR355, OPTIMA MR360 (K103330) | Ge Hangwei Medical Systems Co., Ltd. | 2011-02-11 |