# FDA recall Z-1742-2022

> **Zap Surgical Systems** · Class II · device recall initiated 2022-07-05.

## Product

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.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of AZ, MD, FL, CO and the countries of DEU, CHE, JPN.

## Key facts

- **Recall number:** Z-1742-2022
- **Recalling firm:** Zap Surgical Systems
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-07-05
- **Report date:** 2022-09-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Carlos, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1742-2022

## Citation

> AI Analytics. FDA recall Z-1742-2022. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-1742-2022. Source: US FDA. Licensed CC0.

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