Data Foundry

Medical device recalls 2023

Philips Tempus Pro Patient Monitor — Class II medical device recall Z-2625-2023

Ongoing recall by Remote Diagnostic Technologies Ltd., reported 2023-09-27, distributed in AL, AZ, CA, CO, DC, DE, FL, GA…. Full screen error message may occur on patient monitors with affected hardware version, either during or after

Recall numberZ-2625-2023
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmRemote Diagnostic Technologies Ltd., Farnborough, United Kingdom
Recall initiated2023-08-24
Classified2023-09-21
Reported by FDA2023-09-27
DistributedAL, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI, WV, WY
Quantity3,524
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, and 00-1007, when Used With Tempus Pro Video Laryngoscope, REF 01-2044

Reason for recall

Full screen error message may occur on patient monitors with affected hardware version, either during or after laryngoscopes are unplugged from monitors, informing users a 60-100 second shutdown/restart are required. Error prevents: viewing graphical patient vital signs, sounding of pulse audio tone, visualization of patient airway used during intubation; may lead to treatment delay or hypoxia.

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-2625-2023. 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.