Tempus Pro Patient Monitor is a portable vital signs monitor intended… — Class II medical device recall Z-1321-2023
Ongoing recall by Remote Diagnostic Technologies Ltd., reported 2023-04-12, distributed nationwide. During internal testing, Regulatory Compliance issues were identified regarding the Monitor and Power Supplies
| Recall number | Z-1321-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Remote Diagnostic Technologies Ltd., Farnborough, United Kingdom |
| Recall initiated | 2023-02-23 |
| Classified | 2023-03-31 |
| Reported by FDA | 2023-04-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AF, AT, AU, BE, BO, CA, CH, CZ, DE, DK, ES, FR, GB, HK, IE, IL, IS, IT, KY, LU, MY, NL, NO, PT, RO, SA, SE, SG, SI, TH, ZA |
| Quantity | 5,540 units |
| UPC / GTIN / UDI-DI | 05060472440013, 05060472440020, 05060472441027, 05060472441058, 05060472442901, 05060472442925, 05060472442932 |
| Model numbers | 00-1004, 00-1004-R, 00-1007, 00-1007-R, 00-1024-R, 00-1026-R |
Product
Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel, for the attended or unattended monitoring of single or multiple vital signs in clinical and pre hospital care applications. The affected power supplies are related to the following Tempus Pro Patient Monitoring units: Model Numbers: 00-1004 00-1004-R 00-1007 00-1007-R 00-1024-R 00-1026-R Model Numbers: 00-1004 00-1004-R 00-1007 00-1007-R 00-1024-R 00-1026-R
Reason for recall
During internal testing, Regulatory Compliance issues were identified regarding the Monitor and Power Supplies for fluid ingress and basic safety issues.
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-1321-2023. 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.