Z-1742-2022Class II

ZAP-X Radiosurgery System

Name: Z-1742-2022 ZAP-X Radiosurgery System
Creator: Zap Surgical Systems
Published: 2022-07-05
License: https://open.fda.gov/license/

Zap Surgical Systems Inc. / initiated 2022-07-05 / Open, Classified / root cause: software

FDA source

Zap Surgical Systems began a recall of ZAP-X Radiosurgery System on 2022-07-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1742-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-07-05
Posted: 2022-09-14
Recalling firm: Zap Surgical Systems Inc.
Product: ZAP-X Radiosurgery System
Product code: IYE Accelerator, Linear, Medical
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: 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]
Quantity in commerce: 8
Distribution: Worldwide distribution - US Nationwide distribution in the states of AZ, MD, FL, CO and the countries of DEU, CHE, JPN.
Product codes and lots: UDI-DI: 00860183001504, Serial Numbers, ZUC17152, ZUC17153, ZUC18155, ZUC20157, ZUC20158, ZUC20156, ZUC21161, ZUC21162, using Treatment Delivery Software Version: 1.8.53

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1742-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1742-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-21	2022-09-14

Product code IYE

K211663Class IIZap-X Radiosurgical SystemZap Surgical Systems, Inc. / cleared 2021-07-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)