Z-0717-2007

Kodak Direct View DR3000 System, Stationary X-ray System, Catalog #s 655-1345, 655-1386

Name: Z-0717-2007 Kodak Direct View DR3000 System, Stationary X-ray System, Catalog #s 655-1345, 655-1386
Creator: Carestream Health, Inc.
Published: 2007-03-06
License: https://open.fda.gov/license/

Eastman Kodak Company / initiated 2007-03-06 / Terminated

FDA source

Carestream Health, Inc. began a recall of Kodak Direct View DR3000 System, Stationary X-ray System, Catalog #s 655-1345, 655-1386 on 2007-03-06. The reason FDA records is "The x-ray systems do not indicate the field size when the system's detector is turned off and the collimator is in manual mode. This results in the systems being noncompliant with the field indication performance...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0717-2007
Status: Terminated
Initiated: 2007-03-06
Posted: 2007-07-03
Terminated: 2007-07-02
Recalling firm: Eastman Kodak Company
Product: Kodak Direct View DR3000 System, Stationary X-ray System, Catalog #s 655-1345, 655-1386.
Product code: KPR System, X-Ray, Stationary
Reason for recall: The x-ray systems do not indicate the field size when the system's detector is turned off and the collimator is in manual mode. This results in the systems being noncompliant with the field indication performance standards of section 1020.31(e)(2)& (3) of 21Code of Federal Regulations (CFR).
FDA root cause: Other
Action: On 3/06/07, Eastman Kodak notified CDRH of its proposed Corrective Action Plan (CAP). The CAP was approved by CDRH under the following conditions: (1) Kodak will visit each user facility, and apply dial indicator labels to the collimator knobs, apply a field size label to the collimator housing, and verify that each system complies with the field indication performance standard. (2) Kodak will prepare adequate instructions for the assembly/installation and testing of the dial indicators labels and field size labels. These instructions are to be furnished to all owners of the Kodak Direct View DR3000 Systems. (3) Kodak will supplement the Kodak DR3000 system product report with a copy of the adequate instructions. (4) Kodak will perform 100% verification of the recall effectiveness. (5) Kodak will not charge for the corrections and will reimburse the owner for any out-of-pocket expenses. (6) Kodak will notify the manufacturer of the Ralco 302 ACS collimators, Ralco, that the collimator is noncompliant with the performance standard.
Quantity in commerce: Domestic: 7 units, Canada: 2 units
Distribution: FL, NY, MO, MI, TX, and Canada
Product codes and lots: Serial Numbers DR30001001, DR30001004, DR30001006, DR30001014, DR30001016, DR30001017, DR30001020, DR30001021, DR30000032.

Product code KPR

K060550Class IIKodak Directview Dr 3000 System 64Kw/80kw Generators, Models 6551345, 6551386Eastman Kodak Company / cleared 2006-03-31

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)