FDA Adverse Event
Malfunction
Summary report: N
MRI AND CT SCANNERS
MDR report key: 1750049
·
Received July 1, 2010
Report
- Report Number
- MW5016595
- Event Type
- Malfunction
- Date Received
- July 1, 2010
- Report Date
- July 1, 2010
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- LNH
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PHILIPS HEALTHCARE REFUSES TO SUPPLY REQUIRED INFO PURSUANT TO 21CFR FOR CT AND MRI SCANNERS. MRI SCANNERS REQUIRING INSTALLER INFO, INSTALLER TOOLS, INSTALLER SOFTWARE ACCESS -21CFR 820.170. ACHIEVA 3.0T X SERIES MRI SCANNER ACHIEVA XR ACHIEVA 1.5T INTERA 1.5T, 1.0T, 0.5T NT 1.5T, 1.0T, 0.5T POLARIS -FORMALLY PICKER- 1.0 ECLIPSE -FORMALLY PICKER -1.5 PANORAMA HFO PHILIPS F SERIES MAGNET SYSTEMS -FORMALLY IGC- PHILIPS F-2000 SERIES MAGNET SYSTEMS -FORMALLY IGC- CT SCANNERS REQUIRING INSTALLER INFO, AIAT INFO, INSTALLER TOOLS, INSTALLER SOFTWARE ACCESS -21CFR 820.170, 1020.30-33, 1040.10-11 BRILLIANCE CT -4,8, 16, 32, AND 64- MX8000 CT PQ 5000 -FORMALLY PICKER- PQ 6000 -FORMALLY PICKER- PQZ -FORMALLY PICKER- PQS -FORMALLY PICKER-.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MRI AND CT SCANNERS | MRI AND CT SCANNERS | LNH | PHILIPS HEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |