[Recalled] ZAP-X Radiosurgery System — Software issue identified in cases of initial patient setup with large (greater… | FDA 2022-07-05
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| Product | ZAP-X Radiosurgery System |
|---|---|
| Brand / manufacturer | Zap Surgical Systems |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1742-2022 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 05 July 2022 |
| EAN / barcode | 00860183001504 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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 Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Zap Surgical Systems
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.