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ATLAS TPSS Cable

NEURALYNX, INC. · Model ATLAS TPSS Cable · UDI-DI 00867718000209

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510(k) clearances

475

Adverse events (6 deaths)

Recalls

217

Facilities

Description

The ATLAS TPSS Cable is an adapter that allows signals from an electrode interface to be recorded by not only the ATLAS Neurophysiology System by Neuralynx, Inc. but also other neurophysiology recording systems with touch proof connectors. The ATLAS TPSS Cable shares the outputs from the electrode interface and splits them to both systems to be digitized.

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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Data 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.