Recall record at a glance
| Official record | Z-0004-2023 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Philips North America LLC |
| Report date | Oct 12, 2022 |
| Recall initiation date | Sep 6, 2022 |
| Quantity | 115 US; 193 ROW |
| Location | Cambridge, MA, United States |
Official product description
MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.
Why the product was 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.
Distribution information
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
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.