Zap Surgical Systems 2025-10-08 Health serious FDA
Health · FDA · Recall #FDA-Z-2639-2025
ZAP-X Radiosurgery System, Model: 300150 Recall
Issued October 8, 2025 · Zap Surgical Systems
In October 2025, Zap Surgical Systems recalled the ZAP-X Radiosurgery System, Model: 300150, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
If the radiosurgery system triggers a proximity error message during a long gantry move (greater-than180 degrees), and a subsequent proximity error message occurs after the automatic reduction of speed, a software defect could potentially lead the collimator to collide with patient shoulders or the patient table.
What you should do
- 1 Stop using ZAP-X Radiosurgery System, Model: 300150 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Zap Surgical Systems to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Zap Surgical Systems
- Category
- Health
- Recall date
- October 8, 2025
- Units affected
- Not reported
- Sold at
- Worldwide - US Nationwide distribution in the states of FL, CO, NJ, NY and the countries of Germany, France, Spain, Poland, Republic of Kore
- Recall number
- FDA-Z-2639-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Zap Surgical Systems has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.