Brand Name | ZAP-X RADIOSURGERY SYSTEM |
Type of Device | MEDICAL CHARGED-PARTICLE RADIATION THERAPY SYSTEM |
Manufacturer (Section D) |
ZAP SURGICAL SYSTEMS INC. |
590 taylor way, suite a |
san carlos CA 94070 |
|
Manufacturer (Section G) |
ZAP SURGICAL SYSTEMS INC. |
590 taylor way, suite a |
|
san carlos CA 94070 |
|
Manufacturer Contact |
christopher
brown
|
590 taylor way, suite a |
san carlos, CA 94070
|
|
MDR Report Key | 14716282 |
MDR Text Key | 300469981 |
Report Number | 3012039133-2022-00001 |
Device Sequence Number | 1 |
Product Code |
IYE
|
UDI-Device Identifier | 00860183001504 |
UDI-Public | (01)00860183001504 |
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K211663 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,User Facility |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
06/16/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 300150 |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
04/06/2022 |
Initial Date FDA Received | 06/16/2022 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 06/23/2020 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
|
|