The Recall Desk
ModerateFDA (Devices)·Z-2469-2018·Announced 2018-07-25

Fx Solutions Offset Heads Recalled for Blister Breach

Fx Solutions is recalling specific lots of Humelock Offset 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 hazard is a packaging breach (external blister) which is a low-risk contamination or labeling/packaging issue without reported injuries.

Plain-English summary

Fx Solutions is recalling certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19. The recall is due to a breach in the external blister packaging of these medical devices.

The affected products 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 covers 145 units distributed worldwide, including the United States and various international locations such as France, Argentina, South Africa, Spain, Israel, Germany, Lebanon, Italy, Chile, Belgium, Greece, Mexico, Poland, Hong Kong, and Switzerland.

Healthcare facilities and users should stop using the affected lots immediately and contact Fx Solutions for instructions on return or replacement. The specific lot numbers affected 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 distributed only in France.

The recalled product

Product
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 treatm
Manufacturer
Fx Solutions
Category
Medical Device — Radiation Therapy Equipment
Hazard
Affected units
145

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 (20)

  • 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

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 →

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