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).
Check against the official notice below — it lists the full affected range.
Remote Diagnostic Technologies Ltd. is recalling 510 Tempus Pro patient physiological monitors and arrhythmia detectors (model numbers 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R) with software versions v07.00, v07.01, v07.18, v07.20, v07.22, or v07.24. The devices were distributed worldwide, including across 13 U.S. states and 11 international countries.
The recall was issued because the Tempus Pro (Trizeps 7 only) can cause two error types when used in combination with a specified laryngoscope device and then unplugged. The source document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
The Tempus Pro (Trizeps 7 only) when used in combination with a specified laryngoscope device can cause two error types when subsequently unplugged.
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. Distribution: Worldwide distribution - US Nationwide distribution in the states of FL, TX, PA, MN, UT, MT, CA, WI, VA, NY, TN, KS, MD and the countries of Australia, Austria, Czech Republic, France, Germany, Hong Kong, Israel, Italy, Netherlands, Thailand, Abu Dhabi, UK. Quantity: 510 systems 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.