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Root ZX3

J.MORITA MFG.CORP. · Model RZX3 Type: HF · UDI-DI 04548213056545

EKZ Prescription
1
510(k) clearances
13
Adverse events
1
Recalls
9
Facilities

Description

Model Number had changed from "RZX3 Type: HF" to "RZX3-HF" from 2026-06.

Recalls

DateFirmReason
2006-04-05Macan Engineering and Manufacturing Co., Inc.The product label fails to warn users to use the device on patients with shielded pacemakers only.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.