Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388
FDA Recall Z-3192-2018 · Posted None
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Recalling FirmInvivo Corporation
Recall StatusTerminated
Product CodeMWI
Date Initiated2018-08-03
Date Terminated2021-07-15
Product Quantity38
Reason for Recall
Released with an incorrect, older firmware version installed. May result in intermittent loss of ECG monitoring, inaccurate ECG amplitude display and or auxiliary output, and inaccurate heart rate (HR) displayed due to QRS detection fault.
Firm Action
Philips is asking customers to follow the Action to be Taken by Customer/User section of the August 3, 2018, Field Safety Notice: The Field Safety Notice informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. Philips will replace all affected devices. Users should discontinue use of affected devices immediately. A Philips representative will contact you regarding your affected device.
Root Cause
Software Manufacturing/Software Deployment
Distribution Pattern
Distribution in the Netherlands
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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