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Unimed
Unimed Medical Supplies, Inc. · Model 23M47P · UDI-DI 06936735463510
10
510(k) clearances
622
Adverse events (17 deaths)
12
Recalls
139
Facilities
Description
One-piece ECG Cable Comen 3-lead shielded Grabber end with 1K resistor 12pins plug/AHA
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-01-21 | Physio-Control, Inc. | Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions |
| 2022-02-03 | Volcano Corp | Multi-Modality Touch Screen Modules (MM-TSM), used with integrated IVUS systems, may crack, or become damaged, which may affect their usability. They could become non-functional. T |
| 2019-08-01 | GN Otometrics | The electrode lead connector has a protruding conductor beyond insulation of approximately 0.1 mm. |
| 2019-07-19 | Philips North America, LLC | The thickness of the connector to the trunk cable on affected limb lead sets may be greater than specified. which may prevent or impede the performance of I 2-Lead ECG measurements |
| 2019-05-10 | GE Healthcare, LLC | ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm. |
| 2019-05-10 | GE Healthcare, LLC | ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm. |
| 2019-05-10 | GE Healthcare, LLC | ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm. |
| 2019-05-10 | GE Healthcare, LLC | ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm. |
| 2019-05-10 | GE Healthcare, LLC | ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm. |
| 2014-03-05 | Remington Medical Inc. | Remington Medical discovered an error on the FL-601-97 IFU; part number IFU-RM-0154. Specifically, the polarity for the black chuck in the picture is wrong. It shows (+), but shoul |
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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.