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September 14, 2022
Company: Zap Surgical Systems Date of Enforcement Report: 9/14/2022 Class II PRODUCT ZAP-X Radiosurgery System Recall Number: Z-1742-2022 REASON 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...
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