Model Kodak 2200 Intraoral X-Ray System, Catalog Numbers 5303177, 5303169, 5303151, XR-5154323 -- Carestream Health, Inc. Made in France -- --- 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.
- Company
- Carestream Health, Inc.
- Recall Initiated
- January 24, 2014
- Posted
- March 4, 2014
- Terminated
- June 18, 2015
- Recall Number
- Z-1128-2014
- Quantity
- Domestic: 347 units (total for both)
- Firm Location
- Rochester, NY
Reason for Recall
Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-ray device arms leading to arm breakage.
Distribution
Worldwide distribution. USA (nationwide) and the country of Canada.
Lot / Code Info
Serial Numbers starting with WE, WF, WG, WH, WI, WJ, WK, WL, XA, XB, XC, XD, XE, XF, XG, XH, XI, XJ, XK, XL, YA, YB, YC, YD
Root Cause
Component design/selection
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.
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