RecallRadar

FDA Device recall Z-0806-2020

Kodak DirectView DR3000/3500 - Product Usage: permanently installed as a diagnostic system intended to generate and control x-rays for exam…

On 2020-01-22 the FDA classified a Class II recall of Kodak DirectView DR3000/3500 - Product Usage: permanently installed as a diagnostic system intended to generate and control x-rays for exam… by Carestream Health, citing carestream Health has discovered a potential safety problem that can lead to unintended movement of the U-Arm.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0806-2020
ClassificationClass II
Statusterminated
Initiated2020-01-06
Published2020-01-22
Last updated2026-09-13 11:55 UTC
CompanyCarestream Health
DistributionIA

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

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

Identifiers

code_infoDR3000: 6551360, 6551386, 6551345, 6552160, 6552152, 6551394 DR3500: 6553101, 6553127, 6553119, 6553143, 6553135, 6553036, 6553093

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Other recalls by Carestream Health

All Carestream Health recalls

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0806-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.