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Use caution Medical device recall · FDA · Published September 15, 2017

Hill-Rom Monarch Airway System: EMI Risk for Pacemakers

Hill-Rom recalls Monarch Airway Clearance System Model 1000 with specific serial numbers due to electromagnetic interference risk for pacemakers and defibrillators.

🇺🇸 FDA recall #Z-0192-2018Medical deviceHill-Rom ›
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Recalling firmHILL-ROM MANUFACTURING, INC.1020 County Road F W · Saint Paul, MN 55126-2910
✎ GovInfoNow plain-language explainer

What happened, in plain English

Hill-Rom is recalling certain Monarch Airway Clearance System Model 1000 devices because they may cause electromagnetic interference with implanted pacemakers and defibrillators. This could lead to device malfunction in patients with such medical implants. Read more at govinfonow.com/recall/73012-hill-rom-monarch-airway-system-emi-risk-for-pacemakers.

Source Summary by GovInfoNow · govinfonow.com/recall/73012-hill-rom-monarch-airway-system-emi-risk-for-pacemakers · Updated September 17, 2026 · FDA enforcement record: FDA #Z-0192-2018

Cite this page

“Hill-Rom Monarch Airway System: EMI Risk for Pacemakers.” GovInfoNow, updated September 17, 2026. https://govinfonow.com/recall/73012-hill-rom-monarch-airway-system-emi-risk-for-pacemakers. Based on FDA recall #Z-0192-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0192-2018%22&limit=1).

Why it’s dangerous

The Monarch device emits electromagnetic interference that could disrupt the function of pacemakers and defibrillators. This interference might cause these medical devices to malfunction, potentially leading to health risks for patients with such implants.

Who’s affected

Patients with implanted pacemakers or defibrillators who use the recalled Monarch Airway Clearance System Model 1000 devices are at risk. Healthcare providers using these devices for airway clearance therapy may also be affected.

How to tell if you have this one

Check for the product model number 1000 with serial numbers listed in the recall notice. The device has blue tooth or WIFI capability depending on the product number.

  • Brand
    Hill-Rom
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Device Model

    Look for the model number 1000 on the device label or documentation.

  2. Contact Hill-Rom

    Reach out to Hill-Rom directly for assistance with the recall process.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 24 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: nationwideMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “USA (nationwide) Distribution to the states of: AZ, CA, CO, CT, FL, GA, IA, IL, IN, KY, MA, MI, MN, MO, NE, OH, OK, OR, TN, TX, VA, WA, WI, and WV. Internationally to Canada. There was no military/government distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Iowa, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Ohio, Oklahoma, Oregon, Tennessee, Texas, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA terminated this recall 20 months after the firm started it.

1. Firm started the recall: Sep 15, 201712. FDA classified it Class II: Nov 30, 201723. Published in FDA’s Enforcement Report: Dec 6, 201734. FDA terminated the recall: May 29, 2019420172019
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

How can I tell if my device is recalled?

Check the serial numbers listed in the recall notice: S082VM0092, S122VM0171, and other specific numbers provided in the record.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0192-2018 (September 15, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0192-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on September 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA