FDA Medical Device Recalls (openFDA)
Carestream Health, Inc.: 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.
- Recall number
- Z-0806-2020
- Recalling firm
- Carestream Health, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2020-01-06
- Posted
- not on file
- Terminated
- 2020-05-29
- Reason
- Carestream Health has discovered a potential safety problem that can lead to unintended movement of the U-Arm.
- Root cause
- Component change control
- Action
- On January 6, 2020, the firm distributed Urgent Medical Device Correction letters to affected customers. Users were informed that they may continue to use the system at this time. However, until the correction is executed, Carestream Health strongly recommends against performing any equipment positioning while the patient is near the system to avoid any bodily injury. If the user of the equipment observes any abnormal displacement in the vertical axis during the vertical movement, the device should be removed from use and a service call placed to Carestream (or local dealer) without delay. A Carestream Service Engineer or Carestream Health Authorized Representative will contact user sites and set up a service call to inspect user's devices within the next 6 months to determine whether the inverter parameters are set correctly. If adjustment is needed, the settings will be corrected and proper U-Arm operation will be verified. If you have any questions or concerns, please contact the Carestream Customer Care Center in the U.S. at 1-800-328-2910, available 7 days per week on a 24 hour basis. Outside of the U.S., please call your local Carestream Service support number. If you have distributed the device outside your facility, please alert your customer(s) of this field correction and contact the Carestream Customer Care Center as instructed above.
- Quantity
- 79
- Distribution
- Worldwide distribution in the sate of Iowa and countries of Italy, China, Spain, and Austria.
- Lot, serial or model codes
- DR3000: 6551360, 6551386, 6551345, 6552160, 6552152, 6551394 DR3500: 6553101, 6553127, 6553119, 6553143, 6553135, 6553036, 6553093
- 510(k) numbers
- ["K060550"]
- PMA numbers
- not on file
- Product code
- KPR
- Firm FEI
- 1317307
- Firm city
- Rochester
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28