HILL-ROM MANUFACTURING, INC.: Medical Device Recall in 2017 - (Recall #: Z-0192-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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 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.

Product Classification:

Class II

Date Initiated: September 15, 2017

Date Posted: December 6, 2017

Recall Number: Z-0192-2018

Event ID: 78100

Reason for Recall:

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.

Status: Terminated

Product Quantity: 60 devices

Code Information:

Serial numbers S082VM0092, S122VM0171, S128VM0205, S151VM0242, S082VM0093, S122VM0172, S132VM0210, S151VM0243, S082VM0095, S122VM0175, S132VM0212, S152VM0251, S095VM0119, S122VM0176, S132VM0213, S157VM0257, S095VM0124, S124VM0177, S135VM0216, S157VM0261, S095VM0125, S124VM0178, S136VM0219, S158VM0264, S114VM0152, S124VM0180, S136VM0222, S158VM0266, S119VM0158, S124VM0181, S136VM0223, S158VM0267, S119VM0160, S126VM0187, S138VM0224, S158VM0268, S119VM0161, S126VM0193, S138VM0226, S158VM0271, S119VM0162, S126VM0198, S146VM0227, S158VM0273, S122VM0165, S126VM0199, S146VM0229, S159VM0276, S122VM0166, S128VM0202, S146VM0230, S160VM0279, S122VM0168, S128VM0203, S151VM0238, S167VM0289, S122VM0170, S128VM0204, S151VM0240, and S167VM0291.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated