Z-0274-06

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

Name: Z-0274-06 KODAK DirectView DR 7100 System, Catalog # 133-6049. This is a digital radiology system. The major components...
Creator: Eastman Kodak Co
Published: 2005-10-20
License: https://open.fda.gov/license/

Eastman Kodak Company / initiated 2005-10-20 / Terminated / root cause: manufacturing process

FDA source

Eastman Kodak Co began a recall of KODAK DirectView DR 7100 System, Catalog # 133-6049. This is a digital radiology system. The major components are: operator console; digital imaging capture... on 2005-10-20. The reason FDA records is "Potential weld defect in the Overhead Tube Support assembly which connects the tube assembly to the telescoping arm. This could cause the tube assembly to fall, injuring anyone near the unit". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0274-06
Status: Terminated
Initiated: 2005-10-20
Posted: 2005-12-08
Terminated: 2005-12-30
Recalling firm: Eastman Kodak Company
Product: KODAK DirectView DR 7100 System, Catalog # 133-6049. This is a digital radiology system. The major 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: Potential weld defect in the Overhead Tube Support assembly which connects the tube assembly to the telescoping arm. This could cause the tube assembly to fall, injuring anyone near the unit.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Letters dated 10/20/2005 were hand carried by Kodak Field Service Reps. Kodak Field Engineers inspected units and found the two defective units (both in China).
Quantity in commerce: 3
Distribution: DOMESTIC: 12 units shipped to 12 medical facilities in FL, KY, MI, NY, OH, PA, and SC. FOREIGN: 12 units shipped to 7 hospitals in China, 1 warehouse in China; 1in the possession of Chinese Customs (government); and 1 is in a warehouse in Russia.
Product codes and lots: s/n DR71000121 and DR71000123.

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)