Cathcor/LX/Desktop, System, X-Ray, Angiographic
FDA device recall Z-1032-03 · posted 2003-07-19 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Incorrect CTR values are found when used with ODBC interface, and may result in misdiagnosis.
- Action taken
- A Customer Safety Advisory Letter was sent via registered mail on 10/30/2002.
- Root cause
- Other
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 9
- Distribution
- 5 Hospitals/Clinics in the US.
- Date initiated
- 2002-11-27
- Date posted
- 2003-07-19
- Date terminated
- 2006-10-03
- 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 |
|---|---|---|
| CATHCOR DESKTOP (K002137) | Siemens Elema AB | 2000-10-05 |