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
Check against the official notice below — it lists the full affected range.
Fx Solutions has recalled certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19 medical devices due to breaches in the external blister packaging. These devices are designed to produce and deliver proton beam for treating patients with localized tumors. A total of 131 units across multiple lot numbers have been affected and distributed worldwide, including throughout the United States and 19 other countries.
The affected lot numbers are K237, K238, K239, K240, K689R, K1119, K1120, K1121, K1844, L1730, L1737, L1748, L1756, L1764, L1820, and M1042. The source record does not specify what actions affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19.
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: 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 Quantity: 131 units 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.