i-Cat Classic, 3D Dental Imaging System manufactured by Imaging Sciences International, Hatfield, PA. To be used wheneve
FDA device recall Z-0543-2010 · posted 2009-12-17 · Terminated
Recall details
- Recalling firm
- Imaging Sciences International, LLC
- Reason for recall
- overhead carriage drops quickly
- Action taken
- Imaging Sciences International issued an "Urgent Medical Device Recall" notification dated October 30, 2009 to all customers informing them of the problem and that a field service representative would schedule a visit to install an upgrade kit. For further information, contact Imaging Sciences International at 1-800-205-3570, option 5.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 98 units
- Distribution
- Worldwide Distribution -- Including the United States, Austria, Australia, Belgium, Brazil, Canada, France, Germany, India, Israel, Italy, Jamaica, Spain, South Korea and Taiwan.
- Date initiated
- 2009-10-30
- Date posted
- 2009-12-17
- Date terminated
- 2010-09-30
- Location
- Hatfield, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DVT SCANNER (K051980) | Imaging Sciences Intl., Inc. | 2005-08-19 |