FDA Device recall Z-1997-2021
Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm
- FDA Device
- Class II
- ongoing
- Published 2021-07-07
On 2021-07-07 the FDA classified a Class II recall of Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm by Remote Diagnostic Technologies, citing the Tempus Pro (Trizeps 7 only) when used in combination with a specified laryngoscope device can cause two error types when subsequently unplugged.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1997-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-05-25 |
| Published | 2021-07-07 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Remote Diagnostic Technologies |
| Distribution | US |
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).
Reason
The Tempus Pro (Trizeps 7 only) when used in combination with a specified laryngoscope device can cause two error types when subsequently unplugged.
Identifiers
| code_info | Software version number: v07.00, v07.01, v07.18, v07.20, v07.22, v07.24. UDI No. 12NC No. 05060…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1997-2021%22
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