Model Kodak 2100 Intraoral X-Ray System, Catalog Numbers 5303144, 8011579 -- Carestream Health, Inc. 150 Verona Street R
FDA device recall Z-1127-2014 · posted 2014-03-04 · Terminated
Recall details
- Recalling firm
- Carestream Health Inc.
- Reason for recall
- Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-ray device arms leading to arm breakage.
- Action taken
- Urgent Medical Device Recall Letters (dated 1/24/2014) were sent to the consignees on 1/24/2014 via Certified Mail, Return Receipt Requested.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- EHD
- Quantity affected
- Domestic: 347 units (total for both)
- Distribution
- Worldwide distribution. USA (nationwide) and the country of Canada.
- Date initiated
- 2014-01-24
- Date posted
- 2014-03-04
- Date terminated
- 2015-06-18
- Location
- Rochester, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| KODAK MODELS 2100 AND 2200 (K060292) | Kodak-Trophy | 2006-03-03 |