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, Philips Monitoring Sensor Set, Philips Battery Set Recall
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Philips Medical Systems, Inc.
Lot Codes / Batch Numbers
Batteries with date codes 2808 or earlier.
Products Sold
Batteries with date codes 2808 or earlier.
Philips Medical Systems, Inc. is recalling Lithium Polymer Fiber Optic Module Batteries used in the Intera MR System upgraded to CDAS, Part Num due to VCG battery ignited in a VCG unit when recharging.. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
VCG battery ignited in a VCG unit when recharging.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, CA, FL, GA, IL, IN, MA, MN, NE, NJ, NY, NC, ND, OH, OR, PA, TN, TX, UT, WA, WI
Page updated: Jan 12, 2026