ZAP-X Radiosurgery System
Reported: September 21, 2022 Initiated: July 5, 2022 #Z-1742-2022
Product Description
ZAP-X Radiosurgery System
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.
Details
- Recalling Firm
- Zap Surgical Systems
- Units Affected
- 8
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AZ, MD, FL, CO and the countries of DEU, CHE, JPN.
- Location
- San Carlos, CA
Frequently Asked Questions
What product was recalled? ▼
ZAP-X Radiosurgery System. Recalled by Zap Surgical Systems. Units affected: 8.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 21, 2022. Severity: Moderate. Recall number: Z-1742-2022.
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