PlainRecordsFDA · Medical device recall
GE Healthcare Definium 5000 Digital Radiographic Imaging System… and 1 more product
- Date posted by the FDA
- Sept. 4, 2008
- Status
- Terminated
- Filed by
- GE Healthcare
- Reason
- GE Definium 5000 Collimator failed compliance testing due to a blade sizing issue.
- Distribution pattern
- MD, FL, AZ, TX, MS, NY, OH, CA, GERMANY, and FRANCE.
2 products in this recall
GE Healthcare Definium 5000 Digital Radiographic Imaging System…
- Product
- GE Healthcare Definium 5000 Digital Radiographic Imaging System. Model numbers 5220493. The Definium 5000 System is designed to handle radiographic applications using the digital system. The system configuration includes a choice of elevating or non-elevating or no table, a floor column stand with rotating U-arm, and GE's patented Digital detector that captures radiographic images in digital form, as well as an X-ray generator/power unit.
- Quantity
- 14 devices (12US & 2 OUS)
- Codes and lots
- Model Number 5220493: PC0127XR06, M1973721
- Recall started
- Dec. 17, 2007
- Device type
- System, X-Ray, Stationary
- Root cause (FDA)
- Radiation Control for Health and Safety Act
- What the company told customers
- A consignee letter dated 12/12/07 was sent to consignees (Director or Manager of Radiological Imaging, Clinical Administrator). The letter stated that an installed collimator failed compliance testing because of a blaze sizing issue. A GE Field Engineer site visit was also conducted (FMI No. 10814 12/18/07) to implement the correction. Contact GE Healthcare at 1-262-544-3894.
- Recall number
- Z-1133-2008
GE Healthcare Definium 5000 Digital Radiographic Imaging System…
- Product
- GE Healthcare Definium 5000 Digital Radiographic Imaging System. Model number 5220493-2. The Definium 5000 System is designed to handle radiographic applications using the digital system. The system configuration includes a choice of elevating or non-elevating or no table, a floor column stand with rotating U-arm, and GE's patented Digital detector that captures radiographic images in digital form, as well as an X-ray generator/power unit.
- Quantity
- 14 devices (12US & 2 OUS)
- Codes and lots
- Model Number 5220493-2: 0002695030, 904321DEF5, 480543XR1, 254965D5000, 601855D5K, 914864D5000, 614293D5KX, 239482D5000, 239432D5000, 0002697145, RADNETDEF1, and 239596D5000.
- Recall started
- Dec. 17, 2007
- Device type
- System, X-Ray, Stationary
- Root cause (FDA)
- Radiation Control for Health and Safety Act
- What the company told customers
- A consignee letter dated 12/12/07 was sent to consignees (Director or Manager of Radiological Imaging, Clinical Administrator). The letter stated that an installed collimator failed compliance testing because of a blaze sizing issue. A GE Field Engineer site visit was also conducted (FMI No. 10814 12/18/07) to implement the correction. Contact GE Healthcare at 1-262-544-3894.
- Recall number
- Z-1134-2008
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-1133-2008, Z-1134-2008. The agency record governs; check it and the company before acting.