Device product
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
Z-1307-2015
Product summary
- Event
- Event 69812
- Status
- Terminated
- Classification
- Class II
- Quantity
- 79
- Official record key
device-enforcement:Z-1307-2015
Official wording
Reason: VCG battery ignited in a VCG unit when recharging.
Code information: Batteries with date codes 2808 or earlier.
Distribution pattern: 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
Derived failure modes
-
Unknown
VCG battery ignited in a VCG unit when recharging.