FDA Device recall Z-1307-2015
Lithium Polymer Fiber Optic Module Batteries used in the Intera MR System upgraded to CDAS, Part Number: 9065 and 9067
- FDA Device
- Class II
- terminated
- Published 2015-04-01
On 2015-04-01 the FDA classified a Class II recall of Lithium Polymer Fiber Optic Module Batteries used in the Intera MR System upgraded to CDAS, Part Number: 9065 and 9067 by Philips Medical Systems, citing VCG battery ignited in a VCG unit when recharging.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1307-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-11-20 |
| Published | 2015-04-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Medical Systems |
| Distribution | AL, CA, FL, GA, IL, MA, MN, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, WA, WI |
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
Reason
VCG battery ignited in a VCG unit when recharging.
Identifiers
| code_info | Batteries with date codes 2808 or earlier. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1307-2015%22
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