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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Lithium Polymer Fiber Optic Module Batteries

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  Class 2 Device Recall Philips Lithium Polymer Fiber Optic Module Batteries see related information
Date Initiated by Firm November 20, 2014
Date Posted March 20, 2015
Recall Status1 Terminated 3 on January 23, 2017
Recall Number Z-1307-2015
Recall Event ID 69812
510(K)Number K052078  
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
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
Code Information Batteries with date codes 2808 or earlier.
Recalling Firm/
Manufacturer		 Philips Medical Systems, Inc.
3000 Minuteman Rd
Andover MA 01810-1032
Manufacturer Reason
for Recall		 VCG battery ignited in a VCG unit when recharging.
FDA Determined
Cause 2		 Component design/selection
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.
Quantity in Commerce 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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