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U.S. Department of Health and Human Services

Class 2 Device Recall ZAPX (Treatment Delivery)

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  Class 2 Device Recall ZAPX (Treatment Delivery) see related information
Date Initiated by Firm July 05, 2022
Create Date September 14, 2022
Recall Status1 Open3, Classified
Recall Number Z-1742-2022
Recall Event ID 90716
510(K)Number K211663  
Product Classification Accelerator, linear, medical - Product Code IYE
Product ZAP-X Radiosurgery System
Code Information UDI-DI: 00860183001504, Serial Numbers, ZUC17152, ZUC17153, ZUC18155, ZUC20157, ZUC20158, ZUC20156, ZUC21161, ZUC21162, using Treatment Delivery Software Version: 1.8.53
Recalling Firm/
Manufacturer		 Zap Surgical Systems
590 Taylor Way
San Carlos CA 94070-6307
Manufacturer 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.
FDA Determined
Cause 2		 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, Derek@zapsurgical.com
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.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = IYE and Original Applicant = Zap Surgical Systems, Inc.
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