Brand Name | MOSAIQ |
Type of Device | ACCELERATOR, LINEAR, MEDICAL |
Manufacturer (Section D) |
ELEKTA INC |
100 mathilda place |
5th floor |
sunnyvale, ca CA 94086 |
|
MDR Report Key | 9652138 |
MDR Text Key | 188494077 |
Report Number | 2950347-2020-00004 |
Device Sequence Number | 1 |
Product Code |
IYE
|
UDI-Device Identifier | 00858164002220 |
UDI-Public | 00858164002220 |
Combination Product (y/n) | N |
PMA/PMN Number | K183034 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,o |
Remedial Action |
Recall |
Type of Report
| Initial,Followup |
Report Date |
06/12/2020 |
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 | MOSAIQ |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
01/02/2020
|
Initial Date FDA Received | 01/31/2020 |
Supplement Dates Manufacturer Received | 01/02/2020
|
Supplement Dates FDA Received | 06/12/2020
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|