Z-1997-2021Class II

Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm. Part No. - 00-1004-R, 00-1007-R...

Name: Z-1997-2021 Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm. Part No. - 00-1004-R, 00-1007-R...
Creator: Remote Diagnostic Technologies Ltd.
Published: 2021-05-25
License: https://open.fda.gov/license/

Remote Diagnostic Technologies Ltd. / initiated 2021-05-25 / Open, Classified / root cause: software

FDA source

Remote Diagnostic Technologies Ltd. began a recall of Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm. Part No. - 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. Product Usage: intended to be... on 2021-05-25. FDA classified it as Class II and gives the reason as "The Tempus Pro (Trizeps 7 only) when used in combination with a specified laryngoscope device can cause two error types when subsequently unplugged". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1997-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-05-25
Posted: 2021-07-01
Recalling firm: Remote Diagnostic Technologies Ltd.
Product: Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm. Part No. - 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. Product Usage: intended to be used as a stand-alone monitor or as a telemedicine system (transmitting patient data to other medical professionals located elsewhere).
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: The Tempus Pro (Trizeps 7 only) when used in combination with a specified laryngoscope device can cause two error types when subsequently unplugged.
Root cause tag: software
FDA root cause: Software design
Action: On June 2, 2021, Philips issued an Urgent Medical Device Correction notice to customers via letter and email notifying them an intermittent software error has been detected as a part of an internal production control activity. The error can occur immediately after unplugging the Video Laryngoscope from the USB port. If the customer identifies affected products in use or in inventory: Clinical User Actions: - Users of Tempus Pro who are not using a Video Laryngoscope do not need to take any further actions. - When a Video Laryngoscope is required to be used, the following actions are recommended to reduce the probability of a software reboot during the intervention; - An alternative Video Laryngoscope device may be used to perform any critical interventions such as intubation. - If you are using the Tempus Pro and need to use the Video Laryngoscope on a patient, we recommend completion of any critical interventions before unplugging the Video Laryngoscope from the USB port. - Should the Video Laryngoscope image become frozen on the screen, re-start (turn off and turn back on) the Tempus Pro device. Customer Actions: - Notify all users of the potential risk of loss of monitoring when unplugging the Video Laryngoscope from the Tempus Pro, requiring the device to be restarted. - This issue is limited to specific serial numbers. Please verify that your device is associated with the product included in the scope of this notice utilising attachment 1. - Return your completed Customer Reply form to the email address below, to allow RDT to provide the software update: - Email completed and signed form to: [email protected]
Quantity in commerce: 510 systems
Distribution: Worldwide distribution - US Nationwide distribution in the states of FL, TX, PA, MN, UT, MT, CA, WI, VA, NY, TN, KS, MD and the countries of Australia, Austria, Czech Republic, France, Germany, Hong Kong, Israel, Italy, Netherlands, Thailand, Abu Dhabi, UK.
Product codes and lots: Software version number: v07.00, v07.01, v07.18, v07.20, v07.22, v07.24. UDI No. 12NC No. 05060472440020 989706002081 05060472440013 989706000001 05060472441027 989706000051 05060472441058 989706000101

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1997-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1997-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-07	2021-07-01

Product code MHX

K201746Class IITempus Pro Patient MonitorRemote Diagnostic Technologies Limited / cleared 2020-09-18

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)