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Unimed
Unimed Medical Supplies, Inc. · Model 09096 · UDI-DI 06936735480203
10
510(k) clearances
629
Adverse events (17 deaths)
12
Recalls
139
Facilities
Description
EXTENSION CABLE FOR DOUBLE TEMP GE COMPATIBLE GE Marquette use with YSI400 reusable probe, dural channel 0.3m
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.