🔍 RecallPedia

Fx SOLUTIONS CENTERED HEAD CoCr 50x19, REF 106-5019 Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.

Class I - Dangerous
🏥 Medical Devices Recalled: June 4, 2018 Fx Solutions Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI: 03701037300435 Lot Numbers: K238, K240, K689R, K1119, K1120, K1121, K1844, L1730, L1737, L1748, L1756, L1764, L1820, M1042 OUS only: K237, K239
  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:
Fx Solutions
Reason for Recall:
Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Fx SOLUTIONS CENTERED HEAD CoCr 50x19, REF 106-5019 Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.

Product Codes/Lot Numbers:

UDI: 03701037300435 Lot Numbers: K238, K240, K689R, K1119, K1120, K1121, K1844, L1730, L1737, L1748, L1756, L1764, L1820, M1042 OUS only: K237, K239

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2468-2018

Related Recalls

Fx SOLUTIONS OFFSET HEAD CoCr 50x20, REF 106-5000 Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.

Fx Solutions

Class I - Dangerous

Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19.

Jun 4, 2018 Infusion Pumps Nationwide View Details →