Siemens Biograph mCt-X, model number 10248670. Medical Imaging Equipment.
FDA device recall Z-0162-2010 · posted 2009-11-10 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA Inc.
- Reason for recall
- In the unlikely event that the device is modified to operate in the tilted position, the telescoping support mechanism will not engage properly.
- Action taken
- Siemens Medical Solutions USA, Inc. issued an "Urgent Field Correction - Recall" notice to consignees by letter dated September 3, 2009 informing them of the problem and that a Siemens service representative will be in contact shortly to service the affected product. For further information, contact Siemens at 1-800-888-7436.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 3 units
- Distribution
- Worldwide Distribution -- United States (IL and OH), Germany, France and Hong Kong.
- Date initiated
- 2009-08-11
- Date posted
- 2009-11-10
- Date terminated
- 2009-12-22
- Location
- Knoxville, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIOGRAPH 64 AND BIOGRAPH 40 (K060631) | Siemens Medical Solutions USA, Inc. | 2006-03-17 |