Lithium Polymer Fiber Optic Module Batteries used in the Intera MR System upgraded to CDAS, Part ...
FDA Recall #Z-1307-2015 — Class II — November 20, 2014
Product Description
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.
Recalling Firm
Philips Medical Systems, Inc. — Andover, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
79
Distribution
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
Code Information
Batteries with date codes 2808 or earlier.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.