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| Reason | Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryngoscope issue (related to an August 2023 recall), which could lead to delay in diagnosis, delayed treatment, hypoxia due to unexpected loss of video laryngoscopy and all other monitor measurements during system restart. |
| Product | Inseego USB8 4G Dongle Kit, Part Number: 01-2298, which contains USB Flash Drive, Part Number: 43-2011. The kit is an accessory to the Tempus Pro Monitor, REF: 00-1007-R, 00-1024-R, 00-1026-R |
| Quantity | 55 |
| Distribution | Worldwide - US Nationwide distribution in the states of SC, KY, NV, IA, MI and the country of GB. |
| Initiated | 2025-05-30 |
| Classified | 2025-07-25 |
| Recall number | Z-2175-2025 |
| 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-2175-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97197/
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