Remote Diagnostic Technologies recalls Tempus Pro Patient Monitors with specific model numbers and UDI-DI codes due to regulatory compliance issues involving fluid ingress and basic safety risks in power supplies.
During internal testing, Regulatory Compliance issues were identified regarding the Monitor and Power Supplies for fluid ingress and basic safety issues.
Remote Diagnostic Technologies is recalling Tempus Pro Patient Monitors with certain model numbers and UDI-DI codes because internal testing found regulatory compliance issues with the power supplies. This could lead to fluid ingress and basic safety risks, which may affect clinical use.
The power supplies in the recalled units have regulatory compliance issues that could allow fluid ingress and basic safety risks. These issues may affect the device's performance and safety during clinical use, but the risk is not severe enough to cause serious injury in normal use.
Clinicians and medically qualified personnel who use the Tempus Pro Patient Monitors for vital signs monitoring in clinical or pre-hospital care settings are most at risk. All units with the listed model numbers and UDI-DI codes are affected.
Check the model numbers: 00-1004, 00-1004-R, 00-1007, 00-1007-R, 00-1024-R, 00-1026-R. Also look for UDI-DI codes: 05060472440020, 05060472442901, 05060472440013, 05060472442901, 05060472441027, 05060472442925, 05060472441058, 05060472442932. All products manufactured are affected.
Identify if your Tempus Pro Patient Monitor has model numbers 00-1004, 00-1004-R, 00-1007, 00-1007-R, 00-1024-R, or 00-1026-R.
Look for UDI-DI codes: 05060472440020, 05060472442901, 05060472440013, 05060472442901, 05060472441027, 05060472442925, 05060472441058, or 05060472442932.
Model numbers 00-1004, 00-1004-R, 00-1007, 00-1007-R, 00-1024-R, and 00-1026-R are affected.
UDI-DI codes 05060472440020, 05060472442901, 05060472440013, 05060472442901, 05060472441027, 05060472442925, 05060472441058, and 05060472442932 are affected.
The recall record does not specify a remedy.
We’ve drafted a message you can send Remote Diagnostic Technologies to request your refund or repair — edit it as you like.
Subject: Recall Z-1321-2023 — Remote Diagnostic Technologies Remote Diagnostic Technologies Hello, I own a Remote Diagnostic Technologies that is covered by recall Z-1321-2023 from Remote Diagnostic Technologies. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
