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.
FDA Recall Z-2137-2014 · Posted 2014-08-01
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Reason for Recall
Firm Action
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution-USA (nationwide) and the countries of Canada, China, Italy, Germany, Greece, Kuwait, Spain, South Africa, and United Arab Emirates.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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