PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: October 12, 2022 Initiated: September 6, 2022 #Z-0004-2023

Product Description

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

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.

Details

Recalling Firm
Philips North America Llc
Units Affected
115 US; 193 ROW
Distribution
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
Location
Cambridge, MA

Frequently Asked Questions

What product was recalled?
MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.. Recalled by Philips North America Llc. Units affected: 115 US; 193 ROW.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 12, 2022. Severity: Moderate. Recall number: Z-0004-2023.