Reported Mar 12, 2014 · Terminated
Model Kodak 2100 Intraoral X-Ray System, Catalog Numbers 5303144, 8011579 -- Carestream Health, Inc. 150 Verona Street…
Carestream Health Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Carestream Health Inc. · 150 Verona St · Rochester, NY · 14608-1733
Is this the product you have?
Model Kodak 2100 Intraoral X-Ray SystemCatalog Numbers 53031448011579 -- Carestream HealthInc. 150 Verona Street RochesterNY 14608 -- Made in France -- TROPHY 77435
- Marne La Vallee --- COMMON/USUAL NAMEDental
- X-Ray Systems -- CLASSIFICATION NAMEUnit, X-Ray, Extraoral with timer ---
- There are four major componentsx-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
- Lot codes and dates
- 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
- Amount recalled
- Domestic: 347 units (total for both)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-ray device arms leading to arm breakage.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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