KODAK DirectView DR 9000 System — Class II medical device recall Z-2137-2014
Terminated recall by Carestream Health Inc., reported 2014-08-13, distributed nationwide. A control system failure may cause the U-Arm to move downward unexpectedly when the Radiology Technologist is
| Recall number | Z-2137-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carestream Health Inc., Rochester, NY, United States |
| Recall initiated | 2014-05-30 |
| Classified | 2014-08-01 |
| Reported by FDA | 2014-08-13 |
| Terminated | 2014-12-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CA, CN, DE, ES, GR, IT, KW, ZA |
| Model numbers | 1966688 |
Product
KODAK DirectView DR 9000 System, Catalog Numbers 1966688 (US and Canada) and 8161937 (outside the US and Canada) --- A permanently installed diagnostic x-ray system composed of 3 main components: an operator console, U-Arm assembly with x-ray tube including a collimator, and a stationary generator.
Reason for recall
A control system failure may cause the U-Arm to move downward unexpectedly when the Radiology Technologist is positioning the equipment using the "Up" or "Down" control buttons. Downward movement occurs at three times the normal rate of speed and will continue until the device control button is released, the Emergency Stop button is activated or the equipment Bump Sensor contacts an object.
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-2137-2014. 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.