Recall Z-1128-2014— Carestream Health Inc.
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 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.. 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 recordK-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 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.
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.