Quick Facts at a Glance
- Recall Date
- July 25, 2025
- Hazard Level
- HIGH
- Brand
- Zap Surgical Systems
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Zap Surgical Systems
- Product type
- Radiosurgery System
- Model numbers
- 300150, UDI-DI: 00860183001504, ZUC17153, ZUC20156, ZUC20157, ZUC20159, ZUC21162, ZUC21164 +12 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
July 25, 2025
Reported by FDA DEVICE
October 8, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Zap Surgical Systems or your healthcare provider for instructions. Notification method: Letter
About This Product
The ZAP-X Radiosurgery System is a professional medical device used in radiosurgical treatments. It is designed for precise, targeted radiation therapy. This device operates in a clinical setting under physician supervision.
Why This Is Dangerous
A software defect may trigger a proximity error during extensive gantry movement. If a second proximity error occurs after automatic speed reduction, the collimator could collide with the patient or the table, causing potential injury.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Hospitals and clinics must pause use of affected devices, assess patient schedules, and coordinate with the manufacturer for guidance on patient safety and device remediation.
Practical Guidance
How to identify if yours is affected
- Verify device model 300150 and serial numbers against the recall list.
- Check UDI-DI 00860183001504 on the device label.
- Review software version: TDS V1.10.1 on the unit.
Where to find product info
UDI-DI and serial numbers are located on the device label and in the hospital asset management system.
What timeline to expect
Specific remediation timeline not provided in the notice.
If the manufacturer is unresponsive
- Escalate to hospital risk management and the device manufacturer for an incident report.
- File a recall-related complaint with the FDA if appropriate.
How to prevent similar issues
- Implement an inventory check to identify affected devices.
- Reinforce device-check procedures before use.
- Ensure staff are aware of recall notice and follow manufacturer instructions.
Documentation advice
Keep a copy of the recall notice, serial numbers, UDI, and correspondence with the manufacturer.
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Product Details
Brand: Zap Surgical Systems Product: ZAP-X Radiosurgery System Model: 300150 UDI-DI: 00860183001504 Serial Numbers: ZUC17153, ZUC20156, ZUC20157, ZUC20159, ZUC21162, ZUC21164, ZUC22166, ZUC22169, ZUC22170, ZUC22171, ZUC22173, ZUC22174, ZUC23176, ZUC23177, ZUC24179, ZUC24180, ZUC24181 Software version: TDS V1.10.1 Sold worldwide with US states FL, CO, NJ, NY and countries Germany, France, Spain, Poland, Republic of Korea, Türkiye, Paraguay Price: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Serial numbers include ZUC17153 and ZUC24181
- Software version TDS V1.10.1
- Distributed Worldwide: US (FL, CO, NJ, NY); Germany, France, Spain, Poland, Korea, Türkiye, Paraguay
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Safety Guide
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