Lithium Polymer Fiber Optic Module Batteries used in the Intera MR System upgraded to CDAS, Part Number: 9065 and 9067.
FDA device recall Z-1307-2015 · posted 2015-03-20 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems, Inc.
- Reason for recall
- VCG battery ignited in a VCG unit when recharging.
- Action taken
- Consignees were informed of the recall via letter sent on November 20, 2014 via certified mailing. Field Service Engineers (FSE) will replace all affected batteries.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 79
- Distribution
- Distributed in the following states: AL, CA, FL, GA, IL, MA, MN, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, WA, WI; OUS: Australia, Austria, Belgium, China, Ecuador, Finland, France, Germany, Italy,
- Date initiated
- 2014-11-20
- Date posted
- 2015-03-20
- Date terminated
- 2017-01-23
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACHIEVA, INTERA AND PANORAMA 1.0 RELEASE 2-SERIES (K052078) | Philips Medical Systems Nederland B.V. | 2005-09-07 |