Lithium Polymer Fiber Optic Module Batteries used in the Intera MR… — Class II medical device recall Z-1307-2015
Terminated recall by Philips Medical Systems, Inc., reported 2015-04-01, distributed in AL, CA, FL, GA, IL, MA, MN, NC…. VCG battery ignited in a VCG unit when recharging.
| Recall number | Z-1307-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems, Inc., Andover, MA, United States |
| Recall initiated | 2014-11-20 |
| Classified | 2015-03-20 |
| Reported by FDA | 2015-04-01 |
| Terminated | 2017-01-23 |
| Distributed | AL, CA, FL, GA, IL, MA, MN, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, WA, WI |
| Countries outside the US | AT, AU, BE, CH, CN, DE, EC, FI, FR, GB, IT, JP, MX, NL, SE, SI, ZA |
| Quantity | 79 |
| Model numbers | 9065, 9067 |
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 for recall
VCG battery ignited in a VCG unit when recharging.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1307-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.