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Unipower
UNIPOWER CORPORATION · Model B11192 · UDI-DI 00817392024978
1
510(k) clearances
16,579
Adverse events (943 deaths)
31
Recalls
38
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-10-28 | Remote Diagnostic Technologies Ltd. | Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number. |
| 2024-08-09 | Physio-Control, Inc. | Due to customer complaints and out of box failures, the firm is conducting a voluntary recall as a result of product failures (cracks and over-molding separation of the sterilizabl |
| 2024-05-09 | Remote Diagnostic Technologies Ltd. | 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 |
| 2023-05-08 | Remote Diagnostic Technologies Ltd. | 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 m |
| 2022-01-28 | Remote Diagnostic Technologies Ltd. | Distribution of Defibrillators that are not approved or cleared for distribution US Market. |
| 2020-11-17 | Remote Diagnostic Technologies Ltd. | A software error was detected within software version 1.3.4 for the Tempus LS device. When exiting pacer back into manual mode the pacer pulse wave may put the ECG calibration out |
| 2014-11-06 | ConMed Corporation | Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result |
| 2014-11-06 | ConMed Corporation | Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result |
| 2013-04-26 | Cardio Medical Products | Covidien received customer reports of Arcing/Sparking on the defibrillation electrode leadwire which may affect Cardio Medical Products Inc. defibrillator electrodes Model Number O |
| 2011-03-09 | ConMed Corporation | The product lot was assembled with an R2 Connector, rather than a Zoll Connector. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.