Drug recall
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020
FDA recall event 92251 · Class II · Remote Diagnostic Technologies Ltd.
Key facts
| Event ID | 92251 |
|---|---|
| Recall numbers | Z-1825-2023 |
| Recalling firm | Remote Diagnostic Technologies Ltd. |
| Product type | Devices |
| Products | Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Defibrillator/pacemaker module (DPM) may encounter a problem causing communication from the Mainboard to the DPM to fail, leading to no or ineffective pacing with displayed error message "HW failure… |
| Initiation date | May 8, 2023 |
| Report date | Jun 21, 2023 |
| City | Farnborough |
| Country | United Kingdom |
| FEI number | 3003832357 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: