Philips Expression MR200 MRI Patient Monitoring System.
FDA Recall Z-0958-2015 · Posted 2015-01-13
Advertisement
Recalling FirmInvivo Corporation
Recall StatusTerminated
Product CodeMWI
Date Initiated2014-10-22
Date Terminated2017-01-09
Product Quantity20
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.
Firm 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.
Root Cause
Component design/selection
Distribution Pattern
CA, FL, IN, KY, MN, NC, NJ, NY, OK, SD and TX Netherlands, Poland and United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement