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Zap Surgical Systems Recall 90716

Description: ZAP-X Radiosurgery System

Zap Surgical Systems Recall 90716 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1742-2022
Event ID90716
Event DescriptionZAP-X Radiosurgery System
Product TypeDevices
DistributionWorldwide distribution - US Nationwide distribution in the states of AZ, MD, FL, CO and the countries of DEU, CHE, JPN.
Recall ReasonSoftware 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.
Device Classification20220921
Device Code InfoUDI-DI: 00860183001504, Serial Numbers, ZUC17152, ZUC17153, ZUC18155, ZUC20157, ZUC20158, ZUC20156, ZUC21161, ZUC21162, using Treatment Delivery Software Version: 1.8.53
Center Classification Date20220914
Recall Initiation Date20220705
Recalling FirmZap Surgical Systems
Initial Notification Letter
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