FDA Adverse Event
Other
Summary report: N
1200SX, 600SE, PQ/IQ CT SCANNERS
MDR report key: 1800901
·
Received August 9, 2010
Report
- Report Number
- MW5017053
- Event Type
- Other
- Date Received
- August 9, 2010
- Report Date
- August 9, 2010
- Manufacturer
- PHILIPS MEDICAL BOTHELL WA
- Product Code
- JAK
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE PQ/IQ CT SCANNERS PREDICATE DEVICE IS THE 1200SX CT SCANNER. THE 1200SX DOES NOT SHOW A PREMARKET NOTIFICATION -510K- NUMBER. PHILLIPS HAS NOT PRODUCED A 510K NUMBER. THEREFORE, THE 1200SX, 600SE, PQ/IQ CT SCANNERS IS/OR MAY BE ADULTERATED BY THE DESCRIPTION IN 21 CFR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 1200SX, 600SE, PQ/IQ CT SCANNERS | 1200SX, 600SE, PQ/IQ CT SCANNERS | JAK | PHILIPS MEDICAL BOTHELL WA | 1200SX, 600SE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | 1200SX, 600SE, PQ/IQ CT SCANNERS |