Z-0728-04

Kodak DirectView DR 7100 System, Catalog #133-6049, a digital radiology system. The major system components...

Name: Z-0728-04 Kodak DirectView DR 7100 System, Catalog #133-6049, a digital radiology system. The major system components...
Creator: Eastman Kodak Co
Published: 2004-02-20
License: https://open.fda.gov/license/

Eastman Kodak Company / initiated 2004-02-20 / Terminated

FDA source

Eastman Kodak Co began a recall of Kodak DirectView DR 7100 System, Catalog #133-6049, a digital radiology system. The major system components are: operator console; digital imaging capture... on 2004-02-20. The reason FDA records is "Defective component in overhead tube support balancer may cause the suspended load to fall". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0728-04
Status: Terminated
Initiated: 2004-02-20
Posted: 2004-07-20
Terminated: 2004-05-28
Recalling firm: Eastman Kodak Company
Product: 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.
Product code: KPR System, X-Ray, Stationary
Reason for recall: Defective component in overhead tube support balancer may cause the suspended load to fall.
FDA root cause: Other
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.
Quantity in commerce: 3 units
Distribution: Amsterdam, China and Kuwait.
Product codes and lots: Serial Numbers affected: 4193-5702, 4193-5704, 4193-5705, 4193-5706, 4193-5708

Product code KPR

K001341Class IIDr5000 Dedicated Chest X-Ray SystemAnalogic Corp. / cleared 2000-06-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)