MR Patient Care Portal 5000 — Class II medical device recall Z-0004-2023
Ongoing recall by Philips North America Llc, reported 2022-10-12, distributed in AL, AZ, CA, CO, FL, GA, ID, IL…. Device may intermittently fail to produce audio. Turning the unit off and on does not resolve the issue; disco
| Recall number | Z-0004-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America Llc, Cambridge, MA, United States |
| Recall initiated | 2022-09-06 |
| Classified | 2022-10-03 |
| Reported by FDA | 2022-10-12 |
| Distributed | 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 |
| Countries outside the US | AT, AU, BE, CH, CZ, DE, DK, EE, ES, FI, FR, GB, IE, IT, MT, NL, NO, PL, PT, QA, SE, SG, SK |
| UPC / GTIN / UDI-DI | 00884838091948 |
| Serial numbers | US04100115, US04100116, US04100117, US04100118, US04100119, US04100120, US04100121, US04100122, US04100123, US04100124, US04100125, US04100126, US04100127, US04100128, US04100129, US04100130, US04100131, US04100132, US04100134, US04100135, US04100137, US04100138, US04100139, US04100140, US04100141 and 283 more |
| Model numbers | 453564792561 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0004-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.