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Z-2469-2018 Class II Terminated

Recalled by Fx Solutions — Viriat Rhone-Alpes

Recall Details

Product Type: Devices
Report Date: July 25, 2018
Initiation Date: June 4, 2018
Termination Date: April 5, 2019
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 145 units

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.

Reason for Recall

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

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

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