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

FDA device recall Z-0717-2007 · posted 2007-07-03 · Terminated

Recall details

Recalling firm

Carestream Health, Inc.

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).

Action taken

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.

Root cause

Other

Status

Terminated

Product code

KPR

Quantity affected

Domestic: 7 units, Canada: 2 units

Distribution

FL, NY, MO, MI, TX, and Canada

Date initiated

2007-03-06

Date posted

2007-07-03

Date terminated

2007-07-02

Location

Rochester, NY

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