Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2137-2014 — 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

U.S. FDA — Device Enforcement · United States · 2014-05-30 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2137-2014
Date of alert: 2014-05-30
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Carestream Health Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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