Data Foundry

Medical device recalls 2025

Philips Tempus Pro Patient Monitor — Class II medical device recall Z-1729-2025

Ongoing recall by Remote Diagnostic Technologies Ltd., reported 2025-05-14, distributed nationwide. Patient Monitor software update to address issues:1)May freeze at startup with MPM Application error and Atten

Recall numberZ-1729-2025
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmRemote Diagnostic Technologies Ltd., Farnborough, N/A, United Kingdom
Recall initiated2025-04-15
Classified2025-05-07
Reported by FDA2025-05-14
DistributedNationwide (US)
Quantity6,961
Reason classessoftware
UPC / GTIN / UDI-DI05060472440013, 05060472440020, 05060472440624, 05060472440655, 05060472441027, 05060472441058, 05060472442901, 05060472442918, 05060472442925, 05060472442932
Model numbers00-1004, 00-1004-R, 00-1007, 00-1007-R, 00-1024-R, 00-1026-R

Product

Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007

Reason for recall

Patient Monitor software update to address issues:1)May freeze at startup with MPM Application error and Attention Restart Required messages,2)Monitor may freeze and reboot at start of 12-lead ECG or after, 3)May reboot after intermittent connection with Smart Mount, 4) 12-lead ECG measurements with Louvain algorithm and software before vx.36 could produce inaccurate rhythm/morphology statements.

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-1729-2025. 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.