CLASS II Device recall · Reported 25 Jul 2018 · FDA Enforcement Report

Offset Head CoCr recalled by Fx Solutions

Fx Solutions is recalling Fx Solutions Offset Head CoCr, distributed nationwide in the US. The recall was initiated on 4 Jun 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: 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

Quantity recalled145 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2469-2018
FDA event ID: 80302
Recalling firm: Fx Solutions, Viriat Rhone-Alpes
Classification: Class II
Status: Terminated
Recall initiated: 4 Jun 2018
FDA classified: 17 Jul 2018
Reported: 25 Jul 2018
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

4 Jun 2018	Recall initiated by company
17 Jul 2018	Classified by FDA	+43 days
25 Jul 2018	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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 the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.

Where it was distributed

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

Nationwide

Questions about this recall

Is Offset Head CoCr recalled?

Yes. Fx Solutions recalled Offset Head CoCr on 4 Jun 2018. The recall is Class II and its status is Terminated. Recall number Z-2469-2018.

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Reported	Class	Recall	Company	Reason	Where
25 Jul 2018Device	CLASS II	Centered Head CoCr recalled by Fx Solutions	Fx Solutions	Other	Nationwide

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