Analogic SyneRad Multi Digital Radiology System, Model AN6150
FDA device recall Z-0196-06 · posted 2005-11-24 · Terminated
Recall details
- Recalling firm
- Analogic Corporation
- Reason for recall
- Potential weld defect in the Overhead Tube Support assembly which connects to the telescoping arm. This could cause the tube assembly to fall, leading to possiible injury of the user or patient.
- Action taken
- Analogic Corp notified accounts by email on 10/14/2005 and by letter on 10/17/2005. Accounts are requested to stop use and correction will be conducted by a service engineer.
- Root cause
- Other
- Status
- Terminated
- Product code
- KPR
- Quantity affected
- 17 UNITS
- Distribution
- AZ, CA, FL, MA, OH, PA, TN, TX,
- Date initiated
- 2005-10-14
- Date posted
- 2005-11-24
- Date terminated
- 2015-04-14
- Location
- Peabody, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNERAD MULTI DIGITAL X-RAY SYSTEM, MODEL AN6150 (K040995) | Analogic Corp. | 2004-05-25 |