Model Kodak 2200 Intraoral X-Ray System — Class II medical device recall Z-1128-2014
Terminated recall by Carestream Health Inc., reported 2014-03-12, distributed nationwide. Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-ray device ar
| Recall number | Z-1128-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carestream Health Inc., Rochester, NY, United States |
| Recall initiated | 2014-01-24 |
| Classified | 2014-03-04 |
| Reported by FDA | 2014-03-12 |
| Terminated | 2015-06-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 347 units |
| Reason classes | device malfunction |
| Model numbers | 5303151, 5303169, 5303177, XR-5154323 |
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 for recall
Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-ray device arms leading to arm breakage.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1128-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.