Kodak Directview DR 7500 Dual Detector System (using version 5 software) (2014-02-21)

Starting date:

February 21, 2014

Posting date:

March 21, 2014

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-38491

• Reason
• Affected products

Recalled Products

Kodak Directview DR 7500 Dual Detector System (using version 5 software)

Reason

Carestream has identified that if the system user interrupts the daily switch off-set refresh detector calibration by switching the active detector from one Bucky to another (e.g. table to the wall), and cancels detector calibration within 30 seconds of initiating this process, the previous patient image will be displayed on the console with the current patient's name. The likelihood of this issue occurring is improbable, and there have not been any reported injuries or misdiagnosis as a result.

Affected products