medical Class II Updated 2021-07-07

Remote Diagnostic Technologies Ltd. recalls Tempus Pro - Patient physiological monitor, arrhythmia dete

Recalled 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).


Hazard / Issue

The Tempus Pro (Trizeps 7 only) when used in combination with a specified laryngoscope device can cause two error types when subsequently unplugged.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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
View official government recall

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