CLASS II ONGOING Device recall · Reported 7 Jul 2021 · FDA Enforcement Report
Tempus Pro - Patient physiological monitor recalled
Remote Diagnostic Technologies is recalling Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm, distributed nationwide in the US. The recall was initiated on 25 May 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1997-2021
- FDA event ID
- 88051
- Recalling firm
- Remote Diagnostic Technologies, Basingstoke, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 May 2021
- FDA classified
- 1 Jul 2021
- Reported
- 7 Jul 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Patient Monitors
Timeline
| 25 May 2021 | Recall initiated by company | |
| 1 Jul 2021 | Classified by FDA | +37 days |
| 7 Jul 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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).
Where it was distributed
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.
Nationwide CaliforniaFloridaKansasMarylandMinnesotaMontanaNew YorkPennsylvaniaTennesseeTexasUtahVirginiaWisconsin
Questions about this recall
Why was it recalled?
The Tempus Pro (Trizeps 7 only) when used in combination with a specified laryngoscope device can cause two error types when subsequently unplugged.
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Remote Diagnostic Technologies
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Philips Tempus Pro Patient Monitor recalled | Remote Diagnostic Technologies | Other | Nationwide |
| Device | CLASS II | Inseego USB8 Dongle Kit recalled by Remote Diagnostic Technologies | Remote Diagnostic Technologies | Device Malfunction | Nationwide |
| Device | CLASS II | Philips Tempus Pro Patient Monitor recalled | Remote Diagnostic Technologies | Labeling Errors | Nationwide |
| Device | CLASS II | Tempus Pro Patient Monitor, REFs recalled | Remote Diagnostic Technologies | Device Malfunction | Nationwide |
| Device | CLASS III | Tempus LS-Manual Defibrillator recalled | Remote Diagnostic Technologies | Labeling Errors | Nationwide |
Other Patient Monitors recalls
All 1,022| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | Passport Series Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | T1 Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | cPM Series Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | BeneVision Series Telemetry Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | Panorama and Telemetry Monitoring System recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |