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Terminated

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 Recall Z-1307-2015 · Posted 2015-03-20

Recalling FirmPhilips Medical Systems, Inc.
Recall StatusTerminated
Product CodeLNH
Date Initiated2014-11-20
Date Terminated2017-01-23
Product Quantity79

Reason for Recall

VCG battery ignited in a VCG unit when recharging.

Firm Action

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.

Root Cause

Component design/selection

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052078ACHIEVA, INTERA AND PANORAMA 1.0 RELEASE 2-SERIESPhilips Medical Systems Nederland B.V. · 2005-09-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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