The Recall Desk
HighFDA (Devices)·Z-1997-2021·Announced 2021-07-07

Tempus Pro Patient Monitor Software Error Risk When Unplugged

Remote Diagnostic Technologies is recalling Tempus Pro patient monitors (Trizeps 7 variant) that can produce error states when unplugged while connected to a specified laryngoscope device. No injuries have been reported.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Class II medical device with potential software errors affecting patient monitoring function. No injuries or illnesses reported, and hazard is limited to a specific device combination. Classified as risk-of-harm without reported harm, consistent with High severity.

Plain-English summary

Remote Diagnostic Technologies Ltd. is recalling the Tempus Pro physiological monitor (Trizeps 7 variant), a device designed to monitor patient vital signs and detect arrhythmias, either as a standalone system or as part of a telemedicine setup.

When used in combination with a specified laryngoscope device, the Tempus Pro can produce software error states when subsequently unplugged. The recall affects approximately 510 systems distributed worldwide. No illnesses or injuries have been reported. The U.S. Food and Drug Administration has classified this as a Class II recall (FDA recall number Z-1997-2021).

Affected systems have been distributed in Florida, Texas, Pennsylvania, Minnesota, Utah, Montana, California, Wisconsin, Virginia, New York, Tennessee, Kansas, Maryland, Australia, Austria, Czech Republic, France, Germany, Hong Kong, Israel, Italy, Netherlands, Thailand, Abu Dhabi, and the United Kingdom.

The recalled product

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 lo
Manufacturer
Remote Diagnostic Technologies Ltd.
Category
Medical Device — Patient Monitors
Hazard
  • software-error
  • device-malfunction

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • Software version number: v07.00
  • v07.01
  • v07.18
  • v07.20
  • v07.22

Distribution

Distributed nationwide across the United States.

Related recalls

Same category