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Terminated

Philips Expression MR200 MRI Patient Monitoring System.

FDA Recall Z-0958-2015 · Posted 2015-01-13

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.

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