Zap Surgical Systems recalls ZAP-X Radiosurgery System units with specific serial numbers due to a software issue that may cause incorrect treatment positioning during surgery. Affected units require correction to prevent potential misalignment.
Software issue identified in cases of initial patient setup with large (greater-than-or-equal-to 1.5 degrees) rotational deviations, between digitally reconstructed radiographs, and pre-delivery X-ray images. In these cases the transitional alignment algorithm may incorrectly calculate the new treatment table offset values, leading to an incorrect position for the subsequent treatment isocenter.
Zap Surgical Systems is recalling specific ZAP-X Radiosurgery System units with certain serial numbers because of a software issue that could lead to incorrect treatment positioning during surgery. This risk affects patients undergoing procedures where precise alignment is critical.
The software may miscalculate the treatment table offset values when there are large rotational deviations between digitally reconstructed radiographs and pre-delivery X-ray images. This can cause the treatment isocenter to be positioned incorrectly during surgery, potentially affecting patient safety.
Healthcare providers using the ZAP-X Radiosurgery System with the listed serial numbers are most at risk. Patients undergoing surgery with these systems may experience misaligned treatment if the software issue occurs.
Check for the serial numbers ZUC17152, ZUC17153, ZUC18155, ZUC20157, ZUC20158, ZUC20156, ZUC21161, or ZUC21162 on the ZAP-X Radiosurgery System. These units were sold with Treatment Delivery Software Version 1.8.53.
Verify the software version on your device; affected units have version 1.8.53.
Reach out to Zap Surgical Systems for guidance on correcting the software issue.
The affected units have Treatment Delivery Software Version 1.8.53.
Check for the serial numbers ZUC17152, ZUC17153, ZUC18155, ZUC20157, ZUC20158, ZUC20156, ZUC21161, or ZUC21162 on your ZAP-X Radiosurgery System.
No, but you should check the software version and contact Zap Surgical Systems for correction steps.
We’ve drafted a message you can send Zap Surgical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-1742-2022 — Zap Surgical Systems Zap Surgical Systems Hello, I own a Zap Surgical Systems that is covered by recall Z-1742-2022 from Zap Surgical Systems. 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.
