Carestream Health, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0806-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 6, 2020

Date Posted: January 22, 2020

Recall Number: Z-0806-2020

Event ID: 84616

Reason for Recall:

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

Status: Terminated

Product Quantity: 79

Code Information:

DR3000: 6551360, 6551386, 6551345, 6552160, 6552152, 6551394 DR3500: 6553101, 6553127, 6553119, 6553143, 6553135, 6553036, 6553093

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated