FDAFDA · Food and drugs·Recall number Z-1742-2022
ZAP-X Radiosurgery System
Published September 21, 2022 · Recall initiated: July 5, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zap Surgical Systems
- Distributor
- Worldwide distribution - US Nationwide distribution in the states of AZ, MD, FL, CO and the countries of DEU, CHE, JPN.
- Lot
- UDI-DI: 00860183001504, Serial Numbers, ZUC17152, ZUC17153, ZUC18155, ZUC20157, ZUC20158, ZUC20156, ZUC21161, ZUC21162, using Treatment Delivery Software Version: 1.8.53
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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