Recall Z-1127-2014— Carestream Health Inc.

Name: FDA recall Z-1127-2014
Creator: U.S. Food and Drug Administration
Published: 2014-01-24

Class II · Terminated

Class II FDA medical device recall by Carestream Health Inc., initiated 2014-01-24, terminated 2015-06-18. It names one FDA 510(k) clearance: K060292. Product: 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.. Reason: Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-ray device arms leading to arm breakage..

Recalling firm: Carestream Health Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-01-24
Terminated: 2015-06-18
Firm location: Rochester, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K060292 — KODAK MODELS 2100 AND 2200Kodak-Trophy·cleared 2006-03-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-ray device arms leading to arm breakage.

Data sourced from openFDA. This site is unofficial and independent of the FDA.