FDA recall Z-0806-2020

Carestream Health, Inc. · Class II · device

Product

Kodak DirectView DR3000/3500 - Product Usage: permanently installed as a diagnostic system intended to generate and control x-rays for examination of various anatomical regions. The DR Operator Console is the user interface. All operator functions except positioning the Bucky assembly and controls for the collimator shutter are accomplished at the operator console.

Reason for recall

Carestream Health has discovered a potential safety problem that can lead to unintended movement of the U-Arm.

Distribution

Worldwide distribution in the sate of Iowa and countries of Italy, China, Spain, and Austria.

Key facts

Status
Terminated
Initiation date
2020-01-06
Report date
2020-01-22
Termination date
2020-05-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Rochester, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0806-2020