Recall Z-1307-2015 ยท LNH System, Nuclear Magnetic Resonance Imaging
Philips Medical Systems, Inc.
Lithium Polymer Fiber Optic Module Batteries used in the Intera MR System upgraded to CDAS, Part Number: 9065 and 9067. These rechargeable batteries are used to supply power to the following products: Wireless ECG Module used with the Precess MRI compatible Patient Monitoring System, Wireless SpO2 Module used with the Precess MRI Compatible Patient Monitoring System, Philips Basic Triggering Set
| Date | Mar 20, 2015 (initiated Nov 20, 2014) |
| Status | Terminated |
| Reason | VCG battery ignited in a VCG unit when recharging. |
| Root cause | Component design/selection |
| Action | 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. |
| Quantity | 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, Japan, Mexico, Netherlands, slovenia, South Africa, Sweden, Switzerland, United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052078 | ACHIEVA, INTERA AND PANORAMA 1.0 RELEASE 2-SERIES Philips Medical Systems Nederland B.V., Sep 7, 2005 |