Recall Z-1742-2022— Zap Surgical Systems
Class II · Ongoing
Class II FDA medical device recall by Zap Surgical Systems, initiated 2022-07-05. It names one FDA 510(k) clearance: K211663. Product: ZAP-X Radiosurgery System. 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 treatment table offset values, leading to an incorrect position for the subsequent treatment isocenter..
- Recalling firm
- Zap Surgical Systems
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-07-05
- Firm location
- San Carlos, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.