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.

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

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