medical Class II Updated 2018-07-25

Fx Solutions recalls Fx SOLUTIONS CENTERED HEAD CoCr 50x19, REF 106-5019 Produ

Recalled Product

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.


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI: 03701037300435 Lot Numbers: K238, K240, K689R, K1119, K1120, K1121, K1844, L1730, L1737, L1748, L1756, L1764, L1820, M1042 OUS only: K237, K239
View official government recall

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