High FDA (Devices)·Z-0806-2020·Announced 2020-01-22

Carestream Recalls Kodak DirectView DR3000/3500 X-Ray Systems for U-Arm Movement

Carestream Health is recalling 79 Kodak DirectView DR3000/3500 diagnostic x-ray systems due to a potential safety issue involving unintended movement of the U-Arm.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (unintended movement of a heavy x-ray arm) where no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Carestream Health, Inc. is recalling 79 units of the Kodak DirectView DR3000/3500 diagnostic x-ray systems. These devices are permanently installed systems intended to generate and control x-rays for the examination of various anatomical regions. The recall is being conducted because the company discovered a potential safety problem that can lead to unintended movement of the U-Arm.

The affected units were distributed worldwide, specifically in the state of Iowa and the countries of Italy, China, Spain, and Austria. The recall covers specific serial numbers for both the DR3000 and DR3500 models. The agency has classified this recall as Class II.

Healthcare facilities and users of these diagnostic systems should contact Carestream Health for further instructions regarding the recall and necessary corrective actions.

The recalled product

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 ass
Manufacturer: Carestream Health, Inc.
Category: Medical Device — Diagnostic Imaging
Hazard: unintended-movement
Affected units: 79

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (12)

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

Distribution

Distributed in 1 state:

Same manufacturer · Carestream Health, Inc.

See all →

High
DRX Revolution Mobile X-Ray System Electrical Component Failure Recall
FDA (Devices) · 2023-12-13
High
DRX-Revolution Mobile X-Ray System Generator May Overheat Unexpectedly
FDA (Devices) · 2023-11-15
High
X-ray System Overhead Crane May Continue Moving Unexpectedly
FDA (Devices) · 2023-03-08
Moderate
Carestream OnSight 3D Extremity System Recalled for Software Data Error
FDA (Devices) · 2019-05-01
High
Carestream Recalls DRX-Revolution Mobile X-Ray Systems Due to Assembly Defect
FDA (Devices) · 2017-07-05

Same hazard · unintended movement