Somatom Definition AS, Model number 8098027. Computed tomography x-ray system
FDA device recall Z-0929-2009 · posted 2009-01-23 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- possible improper installation of tilt transport lock/tilt limiter
- Action taken
- The recalling firm received a letter dated 11/25/08 from the manufacturer informing them of the problem. As a result, the recalling firm has issued Update Instruction CT065/08/S to have the transport lock/tilt limiter on the device visually inspected. The tilted scan modes have been disabled until the modified lock/tilt limiter has been installed.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 42 units
- Distribution
- Nationwide Distribution --- including states of AZ, CA, CO, FL, IL, KS, KY, MA, MI, MN, MO, NE, NY, OH, PA, SC, VA, and WY.
- Date initiated
- 2008-12-09
- Date posted
- 2009-01-23
- Date terminated
- 2009-09-23
- Location
- Malvern, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SOMATOM DEFINITION, MODEL AS/AS+ (K081022) | Siemens Medical Solutions USA, Inc. | 2008-06-02 |