Xintec Corp recalls OptiLITE laser surgery fiber assemblies (model CGH1080F) due to incorrect programming causing failure when plugged in. Affected units may not function properly and require replacement.
It has been determined that a lot of fiber lasers were programmed incorrectly. As a result, the fibers from this lot will produce an error and will not allow the user to use the laser when it is plugged in.
Xintec Corp is recalling specific laser surgery fiber assemblies because they were programmed incorrectly. These units may not work when plugged in, which could prevent proper laser use during surgery.
The fiber assemblies were programmed incorrectly in a specific lot, causing them to fail when plugged in. This means the laser may not function properly during surgery, potentially disrupting procedures.
Medical professionals using the OptiLITE laser surgery fiber assemblies for procedures are affected. The risk is low as the issue only affects the specific lot and does not cause immediate harm.
Check for the model number CGH1080F on the device, lot number 21144, and the use-by date of 08/10/2021. The device is for single-use only and sterilized by Sterrad Run 4149.
Verify the model number CGH1080F, lot number 21144, and use-by date 08/10/2021 on the device.
The fiber assemblies were programmed incorrectly in a specific lot, causing them to fail when plugged in.
Check for model number CGH1080F, lot number 21144, and use-by date 08/10/2021 on the device.
The recall does not specify a remedy, so contact Xintec Corp for guidance.
We’ve drafted a message you can send Xintec Corp to request your refund or repair — edit it as you like.
Subject: Recall Z-0162-2020 — Xintec Corp Xintec Corp Hello, I own a Xintec Corp that is covered by recall Z-0162-2020 from Xintec Corp. 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.
