FDA Adverse Event
Malfunction
Summary report: N
SUMMIT SWIVEL COLLIMATOR
MDR report key: 871844
·
Received June 26, 2007
Report
- Report Number
- 1450503-2007-00002
- Event Type
- Malfunction
- Date Received
- June 26, 2007
- Date of Event
- June 8, 2007
- Report Date
- June 8, 2007
- Manufacturer
- SUMMIT INDUSTRIES, INC.
- Product Code
- IZX
- PMA / PMN Number
- K874687
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS INCIDENT IS RELATED TO MFR REPORT# 1450503-2007-00001.
Description of Event or Problem · 1
END USER CALLED SUMMIT DEALER TO ADDRESS "CUT-OFF" ON IMAGES. DEALER SVC REP WENT TO END USER FACILITY AND FOUND COLLIMATOR HANGING BY 2 SCREWS INSTEAD OF 4, TOLD SITE TO DISCONTINUE USE. SUBJECT COLLIMATOR SWIVEL MOUNTING ASSEMBLY WAS REPLACED AND RETURNED TO MANUFACTURER, SUMMIT INDUSTRIES, INC. FOR EVALUATION. THIS INCIDENT IS RELATED TO MFR REPORT# 1450503-2007-00001.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SUMMIT SWIVEL COLLIMATOR | BEAM LIMITING DEVICE | IZX | SUMMIT INDUSTRIES, INC. | D800 | NA851-1193 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |