Class II — Remote Diagnostic Technologies Ltd.
| Recalling firm | REMOTE DIAGNOSTIC TECHNOLOGIES LTD. |
|---|---|
| Registered facility | REMOTE DIAGNOSTIC TECHNOLOGIES LTD. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | The Tempus Pro (Trizeps 7 only) when used in combination with a specified laryngoscope device can cause two error types when subsequently unplugged. |
| 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). |
| Quantity | 510 systems |
| 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. |
| Initiated | 2021-05-25 |
| Classified | 2021-07-01 |
| Recall number | Z-1997-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Remote Diagnostic Technologies Ltd. (Z-1997-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88051/
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