Recall Z-0004-2023 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Philips North America Llc
MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.
| Date | Oct 4, 2022 (initiated Sep 6, 2022) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by 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. |
| Quantity | 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 S |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K212227 | Philips MR Patient Care Portal Invivo Corporation, Sep 30, 2021 |