The Recall Desk
ModerateFDA (Devices)·Z-2468-2018·Announced 2018-07-25

Fx Solutions Proton Beam Therapy Heads Recalled for Blister Breach

Fx Solutions is recalling specific proton beam therapy heads due to a breach in the external blister packaging.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, indicating a moderate risk level.

Plain-English summary

Fx Solutions is recalling specific lots of the Fx SOLUTIONS CENTERED HEAD CoCr 50x19 and Humelock Offset Head 50 X 20 devices. These medical devices are designed to produce and deliver proton beams for the treatment of patients with localized tumors and other conditions susceptible to radiation therapy.

The recall is being conducted because of a breach in the external blister packaging for certain lots of these devices. The affected units were distributed worldwide, including in the United States and various international locations such as France, Germany, and Italy.

Healthcare facilities and users of these devices should stop using the affected lots and contact Fx Solutions for further instructions on how to proceed with the recall.

The recalled product

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 trea
Manufacturer
Fx Solutions
Category
Medical Device — Radiation Therapy Equipment
Hazard
Affected units
131

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (15)

  • UDI: 03701037300435 Lot Numbers: K238
  • K240
  • K689R
  • K1119
  • K1120
  • K1121
  • K1844
  • L1730
  • L1737
  • L1748
  • L1756
  • L1764
  • L1820
  • M1042 OUS only: K237
  • K239

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Fx Solutions under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Fx Solutions

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Same hazard · packaging integrity

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