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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- Manufacturer
- Remote Diagnostic Technologies Ltd.
- Affected units
- 510
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
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