Fx Solutions recalls certain proton beam treatment head models (lot numbers J1123-K1419) due to potential blister breach. This could affect safety during radiation therapy. Affected units sold only in France.
Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19.
Fx Solutions is recalling specific proton beam treatment head models that may have a breach in the external blister. This could pose a safety risk during radiation therapy procedures. The recall affects units sold only in France with specific lot numbers.
The external blister may breach during use, potentially compromising the device's safety mechanism. This could lead to improper radiation delivery during treatment. However, the exact risk mechanism is not clearly described in the recall notice.
Patients receiving radiation therapy for head/neck tumors using the recalled proton beam heads are most at risk. The recall applies only to units sold in France with specific lot numbers.
Check for lot numbers J1123 through K1419 on the device's label. The product was sold only in France. The device is used for proton beam radiation therapy for head and neck tumors.
Look for lot numbers J1123 through K1419 on the device's label to determine if it is affected.
The recall is due to a potential breach in the external blister of certain lots, which could affect safety during radiation therapy.
Check the device label for lot numbers J1123 through K1419. If affected, contact Fx Solutions for further instructions.
The recall notice states that the device may have a breach in the external blister, but does not specify if it is safe to use without action.
We’ve drafted a message you can send Fx Solutions to request your refund or repair — edit it as you like.
Subject: Recall Z-2469-2018 — Fx Solutions Fx Solutions Hello, I own a Fx Solutions that is covered by recall Z-2469-2018 from Fx Solutions. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
