Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0192-2018 — Monarch Airway Clearance System, Model 1000, Product Numbers: PMACS1NA (has blue tooth capability only) and PMACS1WI (has WIFI capability). The firm name on the label is Hill-Rom Services Pte. Ltd., Singapore. The Monarch Airway Clearance System, Model 1000, is intended to provide Airway Clear

U.S. FDA — Device Enforcement · United States · 2017-09-15 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0192-2018
Date of alert: 2017-09-15
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: HILL-ROM MANUFACTURING, INC.
Product category: device
Product type: Devices

Reported risk: Monarch Electromagnetic Interference (EMI) may disrupt the operation of implanted pacemakers or implantable cardioverter defibrillators as well as other devices that might be subject to an EMI if they come into direct contact with the Monarch device.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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