Somatom Definition Model AS/AS+, Model number 8098027. Intended use: Computed Tomography X-ray system
FDA device recall Z-1675-2009 · posted 2009-07-30 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Support mechanism may not engage properly due to improper stowage after opening which may result in internal component damage or potential injury.
- Action taken
- The firm has issued a modification of the telescope support arm parking bracket via Update Instruction CT028/09/S. A firm service representative will install the modified support arm parking brackets on the affected systems.
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 93 units
- Distribution
- Nationwide Distribution -- including states of AR, AZ, CA, CO, CT, FL, IA, IL, IN, KS, KY, MA, MD, MN, MO, MT, NC, ND, NE, NH, NY, OH, PA, SC, SD, TN, VA, WA, WI, and WY.
- Date initiated
- 2009-05-29
- Date posted
- 2009-07-30
- Date terminated
- 2009-09-01
- 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 |