Fx Solutions: Medical Device Recall in 2018 - (Recall #: Z-2469-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 4, 2018

Date Posted: July 25, 2018

Recall Number: Z-2469-2018

Event ID: 80302

Reason for Recall:

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

Status: Terminated

Product Quantity: 145 units

Code Information:

UDI: 03701037300510 Lot Numbers: J1123, K231, K232, K233, K234, K235, K1117, K1118, K1418, K1419, K1625, L1271, L1272, L1727, L1729, L1736, L1747, L1755, L1819, M1041 France only: K532R, L1763

Distribution Pattern:

Worldwide Distribution - US Nationwide and the countries of: France, Argentina, South Africa, Spain, Israel, Germany, Lebanon, Italy, Chile, Belgium, Greece, Mexico, Poland, Hong Kong, Switzerland

Voluntary or Mandated:

Voluntary: Firm initiated