MX8000 Dual v.EXP CT scanner using Version 2.5 software.
FDA device recall Z-1414-05 · posted 2005-08-30 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- When two product applications called Flip and Secondary Capture are used together, it is possible for image orientation labels to be incorrect.
- Action taken
- The firm sent recall/field correction letters dated 3/11/05.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAK
- Distribution
- The devices were distributed to consignees throughout the United States and to consigness located in Argentina, Austria, Bahama, Belarus, Belguim, Brazil, Canada, China, Chile, Columbia, Costa Rica, C
- Date initiated
- 2005-03-11
- Date posted
- 2005-08-30
- Date terminated
- 2012-03-02
- Location
- Cleveland, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MX8000 V5.0 CT SYSTEM (K010817) | Philips Medical Systems (Cleveland), Inc. | 2001-06-15 |