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FIAB SPA · Model A113 · UDI-DI 08054953345864

IKD Prescription

510(k) clearances

475

Adverse events (6 deaths)

Recalls

218

Facilities

Description

FIAB reusable praecordial suction chest electrodes for ECG, ball diameter Ø 33mm and rubber ring diameter Ø 30mm. A113 model has features that make it absolutely reliable during signal recording with all different ECG devices on the market. The metallic part is silver coated (Ag/AgCl) allowing a safe and clear signal transmission. The rings are made of rubber to improve patient’s comfort. FIAB suction chest electrodes thanks to screw and clip connections, can be tapped to all ECG devices and monitors with patient cables which have plug or snap connections. The product is latex-free and without Nickel

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.