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, Philips Monitoring Sensor Set, Philips Battery Set
This recall has been terminated (originally issued March 20, 2015).
- Company
- Philips Medical Systems, Inc.
- Recall Initiated
- November 20, 2014
- Posted
- March 20, 2015
- Terminated
- January 23, 2017
- Recall Number
- Z-1307-2015
- Quantity
- 79
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
VCG battery ignited in a VCG unit when recharging.
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
Lot / Code Info
Batteries with date codes 2808 or earlier.
Root Cause
Component design/selection
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.
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