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QT ECG
Qt Medical, Inc. · Model PCA-A200 · UDI-DI 04719872980339
IKD
Prescription
6
510(k) clearances
459
Adverse events (6 deaths)
11
Recalls
218
Facilities
Description
PCA-A200 Electrode Cable is intended to be used with ECG devices. The Electrode Cable is used to connect electrodes of QT Medical, Inc. placed at appropriate sites on the patient to the Monitor/Defibrillator for general monitoring and/or diagnostic evaluation by healthcare professionals.
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.