Fx Solutions recalls Centered Head CoCr 50x19 models with blister breaches that could affect radiation treatment safety. Affected units include specific lot numbers sold only in the U.S. and Canada.
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 Centered Head CoCr 50x19 models due to a potential blister breach in certain lots. This could compromise the safety of radiation treatment devices if the breach occurs during use.
The external blister in certain lots may breach, potentially affecting the device's ability to safely deliver radiation treatments. This could lead to improper treatment delivery if the breach occurs during use.
Patients receiving radiation treatment for localized tumors or head/neck conditions using the affected Centered Head models are most at risk. The recall applies to specific lot numbers sold in the U.S. and Canada.
Check for lot numbers K238, K240, K689R, K1119, K1120, K1121, K1844, L1730, L1737, L1748, L1756, L1764, L1820, M1042 on the device. The product was sold only in the U.S. and Canada.
Look for the lot number on the device to determine if it is affected (K238, K240, K689R, K1119, K1120, K1121, K1844, L1730, L1737, L1748, L1756, L1764, L1820, M1042).
The external blister in certain lots may breach, potentially affecting the device's ability to safely deliver radiation treatments.
Lot numbers K238, K240, K689R, K1119, K1120, K1121, K1844, L1730, L1737, L1748, L1756, L1764, L1820, M1042.
The affected devices were sold only in the U.S. and Canada.
We’ve drafted a message you can send Fx Solutions to request your refund or repair — edit it as you like.
Subject: Recall Z-2468-2018 — Fx Solutions Fx Solutions Hello, I own a Fx Solutions that is covered by recall Z-2468-2018 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.
