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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- Manufacturer
- Carestream Health, Inc.
- Hazard
- 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:
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