Z-1666-2025Class II

Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R...

Name: Z-1666-2025 Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R...
Creator: Remote Diagnostic Technologies Ltd.
Published: 2025-04-16
License: https://open.fda.gov/license/

Remote Diagnostic Technologies Ltd. / initiated 2025-04-16 / Open, Classified / root cause: design

FDA source

Remote Diagnostic Technologies Ltd. began a recall of Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007 (Tempus Pro non-printer, IBP, with... on 2025-04-16. FDA classified it as Class II and gives the reason as "software issue that causes an error screen on a portable vital signs monitor when attaching video Laryngoscope". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1666-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-04-16
Posted: 2025-04-24
Recalling firm: Remote Diagnostic Technologies Ltd.
Product: Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007 (Tempus Pro non-printer, IBP, with headset dock), 00-1024-R (Tempus Pro printer), 00-1026-R (Tempus Pro printer, IBP), 00-1007 [(Tempus Pro, BT Dock (IB Only)], 00-1004 00-1004 [Tempus Pro (IB Only)]
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: software issue that causes an error screen on a portable vital signs monitor when attaching video Laryngoscope.
Root cause tag: design
FDA root cause: Device Design
Action: On April 16, 2025, Remote Diagnostic Technologies Ltd (subsidiary of Philips) issued a Urgent Medical Device Correction to affected consignees via mail. Philips ask consignees to take the following: 1. DO NOT connect the Video Laryngoscope USB probe to the Tempus Pro during device boot-up. Once Patient Details dialog appears, enter patient data, then plug in the Video Laryngoscope USB probe. 2. If the Tempus Pro Monitor displays the error dialog screen (where the user is asked to restart the device), press the Shutdown Button and restart the Tempus Pro Monitor. 3. Keep a copy of this letter with or near your Tempus Pro Monitor. 4. Complete and return the Urgent Field Safety Notification Response Form included with this letter within 30 days of receipt of this notice. 5. This notice must be shared with all relevant personnel within your organization and with any organization where the potentially affected devices have been transferred.
Quantity in commerce: 6,961 units
Distribution: Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI, WV, WY and the countries of AE, AF, AT, AU, BE, BO, CA, CH, CZ, DE, DK, ES, FI, FR, GB, HK, IE, IL, IS, IT, KY, MY, NL, NO, OM, PL, PT, RO, SA, SE, SG, SI, SL, TH, ZA.
Product codes and lots: All Lots/ UDI-DI(s): 00-1004-R - 05060472440020 & 05060472442901; 00-1007-R - 05060472440013 & 05060472442918; 00-1024-R - 05060472441027 & 05060472442925; 00-1026-R - 05060472441058 & 05060472442932; 00-1004 - 05060472440624; 00-1007 - 05060472440655

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1666-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1666-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-30	2025-04-24

Product code MHX

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)