🔍 RecallPedia

SonarMed AirWave Monitor, Model Number M0001

Class I - Dangerous
🏥 Medical Devices Recalled: April 17, 2017 SonarMed Diagnostic Equipment

What Should You Do?

  1. Check if you have this product:
    UDI Numbers: (01)00851334007001(11)130426(21)339 (01)00851334007001(11)130502(21)342 (01)00851334007001(11)131105(21)365 (01)00851334007001(11)140522(21)369 (01)00851334007001(11)140522(21)373 (01)00851334007001(11)150609(21)379 (01)00851334007001(11)150609(21)381 (01)00851334007001(11)150609(21)382 (01)00851334007001(11)150630(21)383 (01)00851334007001(11)150630(21)385 (01)00851334007001(11)150630(21)386 (01)00851334007001(11)150630(21)388 (01)00851334007001(11)150630(21)389 (01)00851334007001(11)150630(21)390 (01)00851334007001(11)150701(21)391 (01)00851334007001(11)150701(21)393
  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:
SonarMed Inc
Reason for Recall:
Potential for the presence of two error codes which would make the monitor inoperable.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

SonarMed AirWave Monitor, Model Number M0001

Product Codes/Lot Numbers:

UDI Numbers: (01)00851334007001(11)130426(21)339 (01)00851334007001(11)130502(21)342 (01)00851334007001(11)131105(21)365 (01)00851334007001(11)140522(21)369 (01)00851334007001(11)140522(21)373 (01)00851334007001(11)150609(21)379 (01)00851334007001(11)150609(21)381 (01)00851334007001(11)150609(21)382 (01)00851334007001(11)150630(21)383 (01)00851334007001(11)150630(21)385 (01)00851334007001(11)150630(21)386 (01)00851334007001(11)150630(21)388 (01)00851334007001(11)150630(21)389 (01)00851334007001(11)150630(21)390 (01)00851334007001(11)150701(21)391 (01)00851334007001(11)150701(21)393

Distribution:

Distributed in: CA, TX

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2450-2019

Related Recalls