Reported Dec 6, 2017 · Terminated
Monarch Airway Clearance System, Model 1000, Product Numbers: PMACS1NA (has blue tooth capability only) and PMACS1WI…
Hill-Rom Manufacturing, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: HILL-ROM MANUFACTURING, INC. · 1020 County Road F W · Saint Paul, MN · 55126-2910
Is this the product you have?
- Monarch Airway Clearance System, Model 1000
- Product NumbersPMACS1NA (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 Clearance Therapy and promote bronchial drainage where external manipulation of the thorax is the physicians choice of treatment. It is indicated for patients having difficulty with secretion clearance or the presence of atelectasis caused by mucus plugging
- Lot codes and dates
Serial numbers S082VM0092S122VM0171S128VM0205S151VM0242S082VM0093S122VM0172S132VM0210S151VM0243S082VM0095S122VM0175S132VM0212S152VM0251S095VM0119S122VM0176S132VM0213S157VM0257S095VM0124S124VM0177S135VM0216S157VM0261S095VM0125S124VM0178S136VM0219S158VM0264S114VM0152S124VM0180S136VM0222S158VM0266S119VM0158S124VM0181S136VM0223S158VM0267S119VM0160S126VM0187S138VM0224S158VM0268S119VM0161S126VM0193S138VM0226S158VM0271S119VM0162S126VM0198S146VM0227S158VM0273S122VM0165S126VM0199S146VM0229S159VM0276S122VM0166S128VM0202S146VM0230S160VM0279S122VM0168S128VM0203S151VM0238S167VM0289S122VM0170S128VM0204S151VM0240and S167VM0291
- Amount recalled
- 60 devices
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Hill-Rom Manufacturing, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.