ZAP-X Radiosurgery System Software Issue May Cause Treatment Misalignment
A software issue in the ZAP-X Radiosurgery System may cause incorrect treatment positioning in patients with large rotational deviations. The alignment algorithm could miscalculate treatment table offset values, potentially affecting treatment delivery.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device with potential for treatment positioning errors. No illnesses or injuries have been reported to date, making the maximum applicable score 3 per the rubric's criteria for risk-of-harm products without reported injury.
Plain-English summary
The ZAP-X Radiosurgery System is a medical device used for radiation treatment. A software issue affecting initial patient setup has been identified and recalled.
The issue is related to the transitional alignment algorithm, which calculates treatment table positions. When patients have large rotational deviations (1.5 degrees or greater) between digitally reconstructed radiographs and pre-delivery X-ray images, this algorithm may incorrectly calculate the treatment table offset values. This results in an incorrect position for the treatment isocenter.
Eight systems are affected. In the United States, affected systems are located in Arizona, Maryland, Florida, and Colorado. Internationally, affected systems are located in Germany, Switzerland, and Japan. Affected systems are identified by specific serial numbers and use Treatment Delivery Software Version 1.8.53.
The recalled product
- Product
- ZAP-X Radiosurgery System
- Manufacturer
- Zap Surgical Systems
- Category
- Medical Device
- Hazard
- treatment-positioning-error
- software-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- UDI-DI: 00860183001504
- Serial Numbers
- ZUC17152
- ZUC17153
- ZUC18155
- ZUC20157
- ZUC20158
- ZUC20156
- ZUC21161
- ZUC21162
- using Treatment Delivery Software Version: 1.8.53
Distribution
Distributed nationwide across the United States.
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