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U.S. Department of Health and Human Services

Class 2 Device Recall Philips MR200 MRI Patient Monitoring System

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  Class 2 Device Recall Philips MR200 MRI Patient Monitoring System see related information
Date Initiated by Firm October 22, 2014
Date Posted January 13, 2015
Recall Status1 Terminated 3 on January 09, 2017
Recall Number Z-0958-2015
Recall Event ID 69587
510(K)Number K131382  
Product Classification Monitor,physiological,patient(without arrhythmia detection or alarms) - Product Code MWI
Product Philips Expression MR200 MRI Patient Monitoring System.
Code Information Model No. 866120; Lot/ Serial Numbers: US33600065, US33600066, US33600075, US33600077, US33600078, US33600079; US33600080, US33600081, US33600082, US33600083, US33600084, US33600086, US33600087, US33600088, US33600089, US33600090, US33600091, US33600092, US33600093, US33600094.
Recalling Firm/
Manufacturer		 Invivo Corporation
12151 Research Pkwy
Suite 200
Orlando FL 32826-3222
For Additional Information Contact Carolyn N. Oguda
978-659-7197 Ext. 171
Manufacturer Reason
for Recall		 The MR 200 devices failed the initial power up test due to capacitor short and hi-pot testing; possible loss of Patient Monitoring or User/Service Electrical Shock.
FDA Determined
Cause 2		 Component design/selection
Action Philips Medical Systems sent an Urgent - Medical Device Correction Letter dated October 22, 2014, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. Our records indicate that you have an affected device. The following page provides additional instructions and actions that will be taken to address this problem. If you need any further information or support concerning this issue, please contact your local Philips representative: 877-468-4861 option 1, then option 2.
Quantity in Commerce 20
Distribution CA, FL, IN, KY, MN, NC, NJ, NY, OK, SD and TX Netherlands, Poland and 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 = MWI and Original Applicant = INVIVO CORPORATION
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