ZAP-X Radiosurgery System recallZ-1742-2022 · Zap Surgical Systems · initiated Jul 5, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Zap Surgical Systems or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Software design
What the company is doing
On 7/05/22 correction notices were distributed to customers who were told that revised software to address the recall issue would be supplied. Until the firm supplies the revised software follow the following steps to ensure accurate treatment delivery: 1) After using auto-align ensure initial patient setup (prior to treating the first isocenter), has rotational deviations of less than plus-minus 1.5 degrees in each dimension. 2) Prior to commencement of each isocenter beam delivery, verify that rotational deviations remain below plus-minus 1.5 degrees. - Additionally, visually verify patient alignment using image overlay before each subsequent isocenter. 3) Use "auto-align" in cases where the observed rotation deviations exceed plus-minus 1.5 degrees. This will correct the offset to within specifications. 4) Be reminded of the following warning message from IFU E0920-00004 Rev. G Page 49: "Warning: Safe and effective treatment requires accurate patient positioning. It is your responsibility to confirm the final alignment. Carefully observe the KV image and it's correction to the DRR image." The software correction will: - Correct the defect in the transitional alignment algorithm. - Revise the user interface to provide the capability to trend computed rotations in real time during treatment, to better aid the user in identifying possible alignment errors. Customers with additional questions can contact the firm at +1 (408) 933-8477, [email protected]
Recall details
- Recall number
- Z-1742-2022
- Status
- Open, Classified
- Initiated by the company
- Jul 5, 2022
- Recalling firm
- Zap Surgical Systems
- Quantity
- 8
- Product code
- IYE
- FDA submissions
- K211663
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AZ, MD, FL, CO and the countries of DEU, CHE, JPN.
Product description
ZAP-X Radiosurgery System
Code information (models, lots, serial numbers)
UDI-DI: 00860183001504, Serial Numbers, ZUC17152, ZUC17153, ZUC18155, ZUC20157, ZUC20158, ZUC20156, ZUC21161, ZUC21162, using Treatment Delivery Software Version: 1.8.53
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Zap-X Radiosurgery System 300150Zap Surgical Systems, Inc. · Accelerator, Linear, Medical2 recalls1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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