Recall Z-1127-2014 ยท EHD Unit, X-Ray, Extraoral With Timer
Carestream Health Inc.
Model Kodak 2100 Intraoral X-Ray System, Catalog Numbers 5303144, 8011579 -- Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 -- Made in France -- TROPHY 77435 Marne La Vallee --- COMMON/USUAL NAME: Dental X-Ray Systems -- CLASSIFICATION NAME: Unit, X-Ray, Extraoral with timer --- There are four major components: x-ray tube, x-ray generator, collimator and image receptor. These s
| Date | Mar 4, 2014 (initiated Jan 24, 2014) |
| Status | Terminated |
| Reason | Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-ray device arms leading to arm breakage. |
| Root cause | Component design/selection |
| Action | Urgent Medical Device Recall Letters (dated 1/24/2014) were sent to the consignees on 1/24/2014 via Certified Mail, Return Receipt Requested. |
| Quantity | Domestic: 347 units (total for both) |
| Distribution | Worldwide distribution. USA (nationwide) and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060292 | KODAK MODELS 2100 AND 2200 Kodak-Trophy, Mar 3, 2006 |