FDA recall Z-0004-2023

Product

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.

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

Key facts

Status

Ongoing

Initiation date

2022-09-06

Report date

2022-10-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0004-2023