Extended Brilliance Workspace Imaging Workstation. An independent diagnostic viewing and processing workstation, for CT
FDA device recall Z-0889-06 · posted 2006-05-19 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- Due to a software deficiency that occurs in the combine mode, a patients image can be filmed over a different patients image.
- Action taken
- Revised, corrected software has been shipped to consignees beginning June, 2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 397 devices.
- Distribution
- The systems were installed at medical facilities located nationwide and worldwide.
- Date initiated
- 2004-08-02
- Date posted
- 2006-05-19
- Date terminated
- 2012-03-02
- Location
- Cleveland, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MX8000 IDT CT SYSTEM (K012009) | Marconi Medical Systems, Inc. | 2001-09-13 |