Fx Solutions: 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 condi

Is my product affected?

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 th

• UPC 03701037300510

Check against the official notice below — it lists the full affected range.

What happened

Fx Solutions has recalled certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19 devices, which are components used in proton beam treatment systems for cancer patients. The recall affects 145 units distributed worldwide, including throughout the United States and in countries such as France, Germany, Spain, Italy, and others. The devices are being recalled due to a breach in the external blister packaging of certain lots.

The affected lot numbers include J1123, K231, K232, K233, K234, K235, K1117, K1118, K1418, K1419, K1625, L1271, L1272, L1727, L1729, L1736, L1747, L1755, L1819, and M1041, with additional lots K532R and L1763 affecting France only. The recall source does not specify what actions affected consumers or healthcare providers should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

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: 145 units Lot/code info: 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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All FDA (Device enforcement) recalls