FDA Device recall Z-2137-2014
KODAK DirectView DR 9000 System, Catalog Numbers 1966688 (US and Canada) and 8161937 (outside the US and Canada) --- A permanently installe…
- FDA Device
- Class II
- terminated
- Published 2014-08-13
On 2014-08-13 the FDA classified a Class II recall of KODAK DirectView DR 9000 System, Catalog Numbers 1966688 (US and Canada) and 8161937 (outside the US and Canada) --- A permanently installe… by Carestream Health, citing 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. D….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2137-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-05-30 |
| Published | 2014-08-13 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Carestream Health |
| Distribution | US |
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
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.
Identifiers
| code_info | Service Code 1534 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2137-2014%22
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