Zap Surgical Systems recalls ZAP-X Radiosurgery System Model 300150 due to potential software defect causing collimator collision with patient. Affected units have specific serial numbers and software version TDS V1.10.1.
If the radiosurgery system triggers a proximity error message during a long gantry move (greater-than180 degrees), and a subsequent proximity error message occurs after the automatic reduction of speed, a software defect could potentially lead the collimator to collide with patient shoulders or the patient table.
Zap Surgical Systems is recalling its ZAP-X Radiosurgery System Model 300150 because a software defect could cause the collimator to collide with patient shoulders or the table during certain movements. This risk occurs when the system triggers a proximity error message during a long gantry move and then another error after speed reduction.
The software defect can cause the collimator to collide with patient shoulders or the patient table when the system triggers a proximity error message during a long gantry move (over 180 degrees) and then another error after automatic speed reduction. This collision could cause injury during surgical procedures.
Medical professionals using the ZAP-X Radiosurgery System Model 300150 for surgical procedures are most at risk. Patients undergoing surgery with this specific model may also be affected.
Check for serial numbers ZUC17153 through ZUC24181 on the ZAP-X Radiosurgery System Model 300150. The affected units have software version TDS V1.10.1 and UDI-DI number 00860183001504.
Verify the software version is TDS V1.10.1 on the ZAP-X Radiosurgery System Model 300150.
Confirm the unit has a serial number from ZUC17153 to ZUC24181.
The recall is for medical devices used in surgery. Patients may be affected if they undergo procedures with the recalled system, but the recall focuses on the device's safety.
The affected units have software version TDS V1.10.1.
Check the serial number on your device; affected units have serial numbers from ZUC17153 to ZUC24181 and software version TDS V1.10.1.
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-2639-2025 — Zap Surgical Systems Zap Surgical Systems Hello, I own a Zap Surgical Systems that is covered by recall Z-2639-2025 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.
