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 systems are permanently installed diagnostic dental x-ray systems for generation of x-rays for examination of the teeth, jaw and oral structures.
FDA Recall Z-1127-2014 · Posted 2014-03-04
Recalling FirmCarestream Health Inc.
Recall StatusTerminated
Product CodeEHD
Date Initiated2014-01-24
Date Terminated2015-06-18
Product QuantityDomestic: 347 units (total for both)
Reason for Recall
Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-ray device arms leading to arm breakage.
Firm 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.
Root Cause
Component design/selection
Distribution Pattern
Worldwide distribution. USA (nationwide) and the country of Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.