Class II — Zap Surgical Systems
| Recalling firm | Zap Surgical Systems Inc. |
|---|---|
| Registered facility | ZAP SURGICAL SYSTEMS INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | ZAP-X Radiosurgery System |
| Quantity | 8 |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AZ, MD, FL, CO and the countries of DEU, CHE, JPN. |
| Initiated | 2022-07-05 |
| Classified | 2022-09-14 |
| Recall number | Z-1742-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Zap Surgical Systems (Z-1742-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90716/
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