—#131578

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

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K052078
Affected lot / code info: Batteries with date codes 2808 or earlier.

Why it was recalled

VCG battery ignited in a VCG unit when recharging.

Root cause (FDA determination)

Component design/selection

Action the firm took

Consignees were informed of the recall via letter sent on November 20, 2014 via certified mailing. Field Service Engineers (FSE) will replace all affected batteries.

Recalling firm

Firm: Philips Medical Systems, Inc.
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2014-11-20
Posted by FDA: 2015-03-20
Terminated: 2017-01-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #131578. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.