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ATLAS Patient Event Marker
NEURALYNX, INC. · Model ATLAS Patient Event Marker · UDI-DI 00850011306192
IKD
Prescription
6
510(k) clearances
475
Adverse events (6 deaths)
11
Recalls
217
Facilities
Description
The ATLAS Patient Event Marker is an optional configuration of the ATLAS Neurophysiology System that allows the patient to mark an event in the Data Acquisition Software.
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.