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Terminated

Philips Expression MR200 MRI Patient Monitoring System

FDA Recall Z-0069-2015 · Posted 2014-10-15

Recalling FirmInvivo Corporation
Recall StatusTerminated
Product CodeMWI
Date Initiated2014-09-05
Date Terminated2017-10-12
Product Quantity24 units.

Reason for Recall

Failure to produce the Non-Invasive Blood Pressure (NIBP) Measurement.

Firm Action

Philips Medical Systems sent an Urgent - Medical Device Correction letter dated July 9, 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

Process control

Distribution Pattern

Worldwide Distribution - US including the states of CA, GA, MI, NJ, NV, and TX., and the countries of: Austria, Finland, Germany, Poland, Singapore, Sweden, Switzerland and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K131382EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION PORTALInvivo Corporation · 2013-07-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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