| Class 2 Device Recall Philips Lithium Polymer Fiber Optic Module Batteries | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = LNH
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