FDA-Device2022-10-12Class II
MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.
Philips North America Llc
Hazard
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.
Sold states
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
Affected count
115 US; 193 ROW
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0004-2023Don't want to check this manually?
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