Stellant CT Injection System. Powered Injector with Syringe. Angiographic Injector and Syringe. Model numbers S, SX, D,
FDA device recall Z-0154-06 · posted 2005-11-16 · Terminated
Recall details
- Recalling firm
- Medrad Inc
- Reason for recall
- the heat maintainer, an accessory, may overheat and deform the disposable syringe
- Action taken
- The recalling firm issued an Urgent Medical Device Field Correction notice dated 10/12/05 via certified mail. The notice provided instructions to apply warning labels and disconnect the heat maintainer until a field upgrade kit is available. In case where the heat maintainer is a necessity for specific procedures, the customer is being instructed to observe certain precautions.
- Root cause
- Other
- Status
- Terminated
- Product code
- DXT
- Quantity affected
- 4362 units
- Distribution
- The products were shipped to medical facilities nationwide. The products were also shipped to Canada, Isreal, Italy, Denmark, Netherlands, Norway, Great Britain, France, Poland, Germany, Spain, Finlan
- Date initiated
- 2005-10-10
- Date posted
- 2005-11-16
- Date terminated
- 2007-08-15
- Location
- Indianola, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULE (K033881) | Medrad, Inc. | 2004-03-02 |
| MEDRAD STELLANT CT INJECTOR SYSTEM (K023183) | Medrad, Inc. | 2003-01-10 |