Recall Z-0806-2020— Carestream Health, Inc.

Name: FDA recall Z-0806-2020
Creator: U.S. Food and Drug Administration
Published: 2020-01-06

Class II · Terminated

Class II FDA medical device recall by Carestream Health, Inc., initiated 2020-01-06, terminated 2020-05-29. It names one FDA 510(k) clearance: K060550. 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..

Recalling firm: Carestream Health, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-01-06
Terminated: 2020-05-29
Firm location: Rochester, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K060550 — KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386Eastman Kodak Company·cleared 2006-03-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.