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 | Simultaneous ECG measurements with multiple devices, including a manual defibrillator, on the same patient may cause electrical noise or interference, which may lead to distortions of the ECG signal; distortions may lead to no or ineffective pacing, or no or inappropriate defibrillation pulse. |
| Product | Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual |
| Quantity | 1745 |
| Distribution | US Nationwide distribution including in the states of VA, DC, MA, WY, AZ, FL, CA, NM, NJ, TN, OH, KS, IN, NY, IL, TX, NV, NE, PA, AL, IA, GA, MO, KY, WI, OR, CO, WV, WA, ET, UT, ID, OK, MN, ME, MT, MI, NC, ND, MD, DE, VT. |
| Initiated | 2024-05-09 |
| Classified | 2024-06-06 |
| Recall number | Z-2028-2024 |
| 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-2028-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94618/
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