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Open, Classified

MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.

FDA Recall Z-0004-2023 · Posted 2022-10-04

Recalling FirmPhilips North America Llc
Recall StatusOpen, Classified
Product CodeMWI
Date Initiated2022-09-06
Product Quantity115 US; 193 ROW

Reason for Recall

Device may intermittently fail to produce audio. Turning the unit off and on does not resolve the issue; disconnecting and reconnecting to AC power does not reliably resolve the issue.

Firm Action

On September 6, 2022, Philips notified affected customers through URGENT Medical Device Recall letters. A Philips representative will contact customers to arrange a software update. once arranged, a Philips representative will conduct a software update on the device for the customer. Customers should share the recall information with all clinical staff to review and understand. The notice should be placed with the documentation of the MR Patient Care Portal 5000.

Root Cause

Under Investigation by firm

Distribution Pattern

Domestic distribution to AL AZ CA CO FL GA ID IL IN LA MA MI MN NC NE NJ OH PA SC TN TX UT VT WA WY. Foreign distribution to Australia Austria Belgium Czech Republic Denmark Estonia Finland France Germany Ireland Italy Malta Netherlands Norway Poland Portugal Qatar Singapore Slovakia Spain Sweden Switzerland United Kingdom

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K212227Philips MR Patient Care PortalInvivo Corporation · 2021-09-30

Official Source

View FDA Recall →

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

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