Reported Sep 21, 2022 · Ongoing
ZAP-X Radiosurgery System
Zap Surgical Systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zap Surgical Systems · 590 Taylor Way · San Carlos, CA · 94070-6307
Is this the product you have?
- ZAP-X Radiosurgery System
- Lot codes and dates
- UDI-DI
00860183001504Serial NumbersZUC17152ZUC17153ZUC18155ZUC20157ZUC20158ZUC20156ZUC21161ZUC21162using
- Treatment Delivery Software Version1.8.53
- UDI-DI
- Amount recalled
- 8
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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