Reported Jul 7, 2021 · Ongoing
Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm. Part No. - 00-1004-R, 00-1007-R, 00-1024-R,…
Remote Diagnostic Technologies Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Remote Diagnostic Technologies Ltd. · PAVILION C2, ASHWOOD PARK · Basingstoke, N/A · N/A
Is this the product you have?
- Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm. Part No. - 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R
- Product Usageintended to be used as a stand-alone monitor or as a telemedicine system (transmitting patient data to other medical professionals located elsewhere)
- Lot codes and dates
- Software version numberv07.00, v07.01, v07.18, v07.20, v07.22, v07.24. UDI No. 12NC No.
05060472440020989706002081050604724400139897060000010506047244102798970600005105060472441058989706000101
- Software version numberv07.00, v07.01, v07.18, v07.20, v07.22, v07.24. UDI No. 12NC No.
- Amount recalled
- 510 systems
Where it was sold
Why it was recalled
The Tempus Pro (Trizeps 7 only) when used in combination with a specified laryngoscope device can cause two error types when subsequently unplugged.
This product could cause temporary or reversible health problems — stop using it.
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