Computed Tomography system, Diagnostic Imaging: Somatom Sensation 4 Somatom Volume Zoom Somatom Volume Access Somatom Ba
FDA device recall Z-0322-03 · posted 2002-12-05 · Terminated
Recall details
- Recalling firm
- Siemens Medical Systems Inc
- Reason for recall
- Head holder cannot be properly secured on the table top.
- Action taken
- Siemens sent all customers a Update Instruction CT016/02/S document alerting them to the problem. This is their recall notification.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 250
- Distribution
- The firm distributed 75 units to 74 hospitals/clinics throughout the United States. US government accounts are 14. 175 units were distributed to 45 different countries worldwide.
- Date initiated
- 2002-07-10
- Date posted
- 2002-12-05
- Date terminated
- 2003-03-24
- Location
- So Iselin, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SOMATOM P30 CT SYSTEMS (K013522) | Siemens Medical Systems, Inc. | 2001-11-07 |