Medical Intelligence recalls iGuide System software versions 2.2.0, 2.2.1, and 2.2.2 for linear accelerators in radiotherapy. The software may incorrectly demand verification scans when the HexaPOD reaches target position, potentially causing positioning errors during treatment.
Sometimes, although the HexaPOD has reached the target position, the Constant Correlation Check (CCC) can be too sensitive and iGUIDE may incorrectly demand a verification scan.
Medical Intelligence is recalling iGuide System software versions 2.2.0, 2.2.1, and 2.2.2 for linear accelerators used in radiotherapy. The software may incorrectly demand verification scans when the HexaPOD reaches the target position, which could lead to positioning errors during treatment.
The software may incorrectly demand verification scans when the HexaPOD reaches the target position. This could cause positioning errors during radiotherapy treatments, potentially affecting treatment accuracy.
Users of the iGuide System software versions 2.2.0, 2.2.1, and 2.2.2 on specific linear accelerator models like VERSA HD and ELEKTA INFINITY. Patients receiving radiotherapy treatments using these systems are most at risk.
Check if your iGuide System software is version 2.2.0, 2.2.1, or 2.2.2. The affected units are specific linear accelerator models like VERSA HD and ELEKTA INFINITY with serial numbers listed in the recall notice.
Verify your iGuide System software version by checking the device settings or documentation.
Update to the latest software version if available through the manufacturer's support channels.
Check if your software version is 2.2.0, 2.2.1, or 2.2.2 on a VERSA HD or ELEKTA INFINITY linear accelerator model with the serial numbers listed in the recall notice.
The recall notice does not specify a software update process. Contact Medical Intelligence for assistance.
No, the recall does not require immediate discontinuation of use. The hazard is low risk and can be addressed with software updates.
We’ve drafted a message you can send Medical Intelligence to request your refund or repair — edit it as you like.
Subject: Recall Z-2082-2019 — Medical Intelligence Medical Intelligence Hello, I own a Medical Intelligence that is covered by recall Z-2082-2019 from Medical Intelligence. 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.
