Kodak DirectView DR 7100 System, Catalog #133-6049, a digital radiology system. The major system components are: operator console; digital imaging capture device; tilting table with floating top; ceiling-mounted x-ray tube; x-ray generator timing and distribution unit.
FDA Recall Z-0728-04 · Posted 2004-07-20
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Recalling FirmEastman Kodak Co
Recall StatusTerminated
Product CodeKPR
Date Initiated2004-02-20
Date Terminated2004-05-28
Product Quantity3 units
Reason for Recall
Defective component in overhead tube support balancer may cause the suspended load to fall.
Firm Action
2/20/2004: Field representatives notified the customer in China that the unit should not be used until the OTS Balancer component can be repaired/replaced.
Root Cause
Other
Distribution Pattern
Amsterdam, China and Kuwait.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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