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U.S. Department of Health and Human Services

Class 2 Device Recall ZAPX Radiosurgery System

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 Class 2 Device Recall ZAPX Radiosurgery Systemsee related information
Date Initiated by FirmJuly 25, 2025
Date PostedSeptember 26, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2639-2025
Recall Event ID 97413
510(K)NumberK211663 
Product Classification Accelerator, linear, medical - Product Code IYE
ProductZAP-X Radiosurgery System, Model: 300150
Code Information 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
Recalling Firm/
Manufacturer		 Zap Surgical Systems
590 Taylor Way
San Carlos CA 94070-6307
Manufacturer 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.
FDA Determined
Cause 2		Software change control
ActionOn 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 Derek@zapsurgical.com
Quantity in Commerce17
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = IYE
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