GD

General Devices · Model Prep-Check Plus, 25 pin · UDI-DI 00862186000331

510(k) clearances

Adverse events (2 deaths)

Recalls

Facilities

Description

The Prep-Check Plus, 25 pin is a hand-held, battery powered device intended to measure the electrical impedance of bio-potential electrodes applied to patients. It has 25 Lead EEG with 25 Pin Female "D" Connector (All 25 Pins Wired) .

Recalls

Date	Firm	Reason
2018-07-02	Hudson Scientific LLC	The device and its accessories may not have been manufactured according to current Good Manufacturing Practices. In addition, the firm has received three complaints regarding elect
2015-11-23	ZYTO Technologies, Inc.	ZYTO Technologies Inc. Announces a Voluntary Recall of the ZYTO Tower and ZYTO Select and Elite Software Due to Claims Exceeding the 510(k) Clearance.
2015-11-23	ZYTO Technologies, Inc.	ZYTO Technologies Inc. Announces a Voluntary Recall of the ZYTO Tower and ZYTO Select and Elite Software Due to Claims Exceeding the 510(k) Clearance.

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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.