FDA Adverse Event
Summary report: N
PACS
MDR report key: 1329085
·
Received February 5, 2009
Report
- Report Number
- 3004526608-2009-00006
- Date Received
- February 5, 2009
- Report Date
- July 20, 2006
- Manufacturer
- GE HEALTHCARE INTEGRATED IT SOLUTIONS
- Product Code
- LLZ
- PMA / PMN Number
- K043415
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THERE WAS NO REPORTED PATIENT INJURY ASSOCIATED WITH THIS EVENT. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT SINUS IMAGES ARE FLIPPED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PACS | PACS SERVER | LLZ | GE HEALTHCARE INTEGRATED IT SOLUTIONS | S/W VERSION 2.1 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |