Tempus Pro — Class II medical device recall Z-1997-2021
Ongoing recall by Remote Diagnostic Technologies Ltd., reported 2021-07-07, distributed nationwide. The Tempus Pro (Trizeps 7 only) when used in combination with a specified laryngoscope device can cause two er
| Recall number | Z-1997-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Remote Diagnostic Technologies Ltd., Basingstoke, N/A, United Kingdom |
| Recall initiated | 2021-05-25 |
| Classified | 2021-07-01 |
| Reported by FDA | 2021-07-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, CZ, DE, FR, GB, HK, IL, IT, NL, TH |
| Quantity | 510 systems |
| UPC / GTIN / UDI-DI | 05060472440013, 05060472440020, 05060472441027, 05060472441058 |
| Model numbers | 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R |
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 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.
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-1997-2021. 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.