🔍 RecallPedia

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.

Class I - Dangerous
🏥 Medical Devices Recalled: September 15, 2017 HILL-ROM MANUFACTURING Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    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.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
HILL-ROM MANUFACTURING, INC.
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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 Codes/Lot Numbers:

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.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0192-2018

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