Z-2639-2025Class II

ZAP-X Radiosurgery System, Model: 300150

Name: Z-2639-2025 ZAP-X Radiosurgery System, Model: 300150
Creator: Zap Surgical Systems
Published: 2025-07-25
License: https://open.fda.gov/license/

Zap Surgical Systems Inc. / initiated 2025-07-25 / Open, Classified / root cause: software

FDA source

Zap Surgical Systems began a recall of ZAP-X Radiosurgery System, Model: 300150 on 2025-07-25. FDA classified it as Class II and gives the reason as "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...". 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-2639-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-07-25
Posted: 2025-09-26
Recalling firm: Zap Surgical Systems Inc.
Product: ZAP-X Radiosurgery System, Model: 300150
Product code: IYE Accelerator, Linear, Medical
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software change control
Action: On 7/25/2025, correction notices were sent to customers who were asked to do the following: Firm will be revising the software to address this issue. Until we supply you with the revised software, the firm strongly advises that you follow these steps to prevent potential collisions. 1. In the rare event that the system triggers a proximity error message during a long gantry move (greater-than-180-degrees), and a subsequent proximity error message occurs after the automatic reduction of speed, please manually extract the patient. 2. After the patient has been safely extracted, please return the gantry to its home position before resuming any treatment procedures. If you have any further questions related to this situation email [email protected]
Quantity in commerce: 17
Distribution: Worldwide - US Nationwide distribution in the states of FL, CO, NJ, NY and the countries of Germany, France, Spain, Poland, Republic of Korea, T¿rkiye, Paraguay.
Product codes and lots: UDI-DI: 00860183001504, Serial Numbers: ZUC17153, ZUC20156, ZUC20157, ZUC20159, ZUC21162, ZUC21164, ZUC22166, ZUC22169, ZUC22170, ZUC22171, ZUC22173, ZUC22174, ZUC23176, ZUC23177, ZUC24179, ZUC24180, ZUC24181. Software version: TDS V1.10.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2639-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2639-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-10-08	2025-09-26

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)