The Recall Desk
SevereFDA (Devices)·Z-1307-2015·Announced 2015-04-01

Philips Recalls Lithium Polymer Fiber Optic Module Batteries Due to Ignition Risk

Philips Medical Systems is recalling 79 lithium polymer fiber optic module batteries used in Intera MR Systems because a battery ignited during recharging.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a fire hazard (ignition) in a medical device, which aligns with the rubric criterion for 'significant injury/property-damage reports' or high-risk structural defects, warranting a Severe classification.

Plain-English summary

Philips Medical Systems, Inc. is recalling 79 Lithium Polymer Fiber Optic Module Batteries, Part Numbers 9065 and 9067. These rechargeable batteries are used to supply power to various patient monitoring modules and sensor sets used with the Intera MR System upgraded to CDAS and the Precess MRI compatible Patient Monitoring System.

The recall was initiated because a VCG battery ignited in a VCG unit when recharging. The affected batteries have date codes 2808 or earlier.

These batteries were distributed in 20 US states and 17 countries, including Australia, Austria, Belgium, China, and the United Kingdom. Users should stop using the affected batteries immediately and contact Philips Medical Systems for instructions on replacement or repair.

The recalled product

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 S
Affected units
79

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Batteries with date codes 2808 or earlier.

Distribution