Z-0806-2020Class II

Kodak DirectView DR3000/3500 -

Name: Z-0806-2020 Kodak DirectView DR3000/3500 -
Creator: Carestream Health, Inc.
Published: 2020-01-06
License: https://open.fda.gov/license/

Eastman Kodak Company / initiated 2020-01-06 / Terminated

FDA source

Carestream Health, Inc. began a recall of Kodak DirectView DR3000/3500 - Product Usage: permanently installed as a diagnostic system intended to generate and control x-rays for examination of various... on 2020-01-06. FDA classified it as Class II and gives the reason as "Carestream Health has discovered a potential safety problem that can lead to unintended movement of the U-Arm". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0806-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-06
Posted: 2020-01-13
Terminated: 2020-05-29
Recalling firm: Eastman Kodak Company
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.
Product code: KPR System, X-Ray, Stationary
Reason for recall: Carestream Health has discovered a potential safety problem that can lead to unintended movement of the U-Arm.
FDA 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 in commerce: 79
Distribution: Worldwide distribution in the sate of Iowa and countries of Italy, China, Spain, and Austria.
Product codes and lots: DR3000: 6551360, 6551386, 6551345, 6552160, 6552152, 6551394 DR3500: 6553101, 6553127, 6553119, 6553143, 6553135, 6553036, 6553093

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0806-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0806-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-22	2020-01-13

Product code KPR

K060550Class IIKodak Directview Dr 3000 System 64Kw/80kw Generators, Models 6551345, 6551386Eastman Kodak Company / cleared 2006-03-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)