The Recall Desk
HighFDA (Devices)·Z-0192-2018·Announced 2017-12-06

Hill-Rom Recalls Monarch Airway Clearance Systems Due to EMI Risk

Hill-Rom is recalling 60 Monarch Airway Clearance Systems because electromagnetic interference may disrupt implanted pacemakers or defibrillators.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (potential disruption of life-sustaining implanted devices) where specific injury or illness has not yet been reported, fitting the High severity criteria.

Plain-English summary

Hill-Rom Manufacturing, Inc. is recalling 60 units of the Monarch Airway Clearance System, Model 1000. The affected devices include product numbers PMACS1NA (Bluetooth capability) and PMACS1WI (WiFi capability). The firm name on the label is Hill-Rom Services Pte. Ltd., Singapore. The device is intended to provide Airway Clearance Therapy and promote bronchial drainage for patients with difficulty clearing secretions or atelectasis caused by mucus plugging.

The recall is due to a risk that the Monarch device's electromagnetic interference (EMI) may disrupt the operation of implanted pacemakers or implantable cardioverter defibrillators (ICDs) if they come into direct contact with the Monarch device. Other devices subject to EMI may also be affected by direct contact.

The affected devices were distributed nationwide in the United States 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, as well as internationally to Canada. There was no military or government distribution. Users should check their device serial numbers against the list provided by the FDA to determine if their unit is affected.

The recalled product

Product
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
Manufacturer
HILL-ROM MANUFACTURING, INC.
Category
Medical Device — Respiratory / Airway Clearance
Hazard
Affected units
60

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Serial numbers S082VM0092
  • S122VM0171
  • S128VM0205
  • S151VM0242
  • S082VM0093
  • S122VM0172
  • S132VM0210
  • S151VM0243
  • S082VM0095
  • S122VM0175
  • S132VM0212
  • S152VM0251
  • S095VM0119
  • S122VM0176
  • S132VM0213
  • S157VM0257
  • S095VM0124
  • S124VM0177
  • S135VM0216
  • S157VM0261

Distribution

Distributed nationwide across the United States.

The notice also names 24 states specifically:

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