NA
FIAB SPA · Model F8725RAHA · UDI-DI 08033695726353
IKD
Prescription
6
510(k) clearances
459
Adverse events (6 deaths)
11
Recalls
218
Facilities
Description
ECG patient cables with die casting derivation box, with defibrillator protection, Resistance 10 kOhm, with 4mm plug
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-07-02 | Stryker Sustainability Solutions | Disposable 5 lead cable and lead wire system package that should contain lead systems, lead telemetry systems and a dual connect cable, may in fact contain, different ECG Leads, wh |
| 2021-08-09 | Ad-Tech Medical Instrument Corporation | Incorrect version of labels were used. |
| 2021-08-09 | Ad-Tech Medical Instrument Corporation | Incorrect version of labels were used. |
| 2021-08-09 | Ad-Tech Medical Instrument Corporation | Incorrect version of labels were used. |
| 2019-02-22 | GE Healthcare, LLC | The Integrated ECG cable with 3-lead leadwires can short circuit during defibrillation and conduct 25% of the defibrillation energy away from the patient. |
| 2017-03-31 | Oscor, Inc. | The Reusable Oscor ATAR extension cables could separate from the connector during use. |
| 2017-03-31 | Oscor, Inc. | The Reusable Oscor ATAR extension cables could separate from the connector during use. |
| 2016-03-29 | Ad-Tech Medical Instrument Corporation | Ad-Tech is recalling unopened/unused sterile cables intended to be used only with all compatible Ad-Tech electrodes for the purpose of connecting these electrodes to third party mo |
| 2011-06-01 | St. Jude Medical | St. Jude Medical is recalling a single lot (3334664) of Supreme Electrophysiology Extension Cable which were packaged with a Quadripolar cable instead of a hexapolar Cable. St. J |
| 2011-02-08 | Vermed, Inc. | Vermed kits contain a product component (Triad Alcohol Prep Pads) recalled due to potential Bacillus cereus contamination. |
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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.