FDA Adverse Event
Malfunction
Summary report: N
ZAP-X RADIOSURGERY SYSTEM
MDR report key: 14716282
·
Received June 16, 2022
Report
- Report Number
- 3012039133-2022-00001
- Event Type
- Malfunction
- Date Received
- June 16, 2022
- Date of Event
- April 6, 2022
- Report Date
- June 16, 2022
- Manufacturer
- ZAP SURGICAL SYSTEMS INC.
- Product Code
- IYE
- UDI-DI
- 00860183001504
- PMA / PMN Number
- K211663
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
DURING TREATMENT, TRACKING ALGORITHM HAD DIFFICULTIES ALIGNING PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1937656 | ZAP-X RADIOSURGERY SYSTEM | MEDICAL CHARGED-PARTICLE RADIATION THERAPY SYSTEM | IYE | ZAP SURGICAL SYSTEMS INC. | 300150 | 00860183001504 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |