The Recall Desk
HighFDA (Devices)·Z-2137-2014·Announced 2014-08-13

Carestream KODAK DirectView DR 9000 X-Ray System Recalled for Control Failure

Carestream Health is recalling KODAK DirectView DR 9000 systems because a control failure may cause the U-Arm to move downward unexpectedly at three times the normal speed.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product where injury has not yet been reported, meeting the criteria for a High severity score.

Plain-English summary

Carestream Health Inc. is recalling the KODAK DirectView DR 9000 System, a permanently installed diagnostic x-ray system. The recall involves 100 units distributed in the United States and 46 units distributed in Canada, China, Italy, Germany, Greece, Kuwait, Spain, South Africa, and the United Arab Emirates.

The recall is due to a control system failure that may cause the U-Arm to move downward unexpectedly while a radiology technologist is positioning the equipment using the "Up" or "Down" control buttons. When this failure occurs, the downward movement happens at three times the normal rate of speed and continues until the device control button is released, the Emergency Stop button is activated, or the equipment Bump Sensor contacts an object.

Healthcare facilities should contact Carestream Health for instructions on how to resolve the issue. The recall is classified as FDA Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

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
Manufacturer
Carestream Health Inc.
Category
Medical Device — Diagnostic Imaging
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Service Code 1534

Distribution

Distributed nationwide across the United States.

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