Z-2137-2014Class II

KODAK DirectView DR 9000 System, Catalog Numbers 1966688 (US and Canada) and 8161937 (outside the US and...

Name: Z-2137-2014 KODAK DirectView DR 9000 System, Catalog Numbers 1966688 (US and Canada) and 8161937 (outside the US and...
Creator: Carestream Health Inc.
Published: 2014-05-30
License: https://open.fda.gov/license/

Eastman Kodak Company / initiated 2014-05-30 / Terminated / root cause: manufacturing process

FDA source

Carestream Health Inc. began a recall of KODAK DirectView DR 9000 System, Catalog Numbers 1966688 (US and Canada) and 8161937 (outside the US and Canada) --- A permanently installed diagnostic x-ray... on 2014-05-30. FDA classified it as Class II and gives the reason as "A control system failure may cause the U-Arm to move downward unexpectedly when the Radiology Technologist is positioning the equipment using the "Up" or "Down" control buttons. Downward movement occurs at three times...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2137-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-30
Posted: 2014-08-01
Terminated: 2014-12-17
Recalling firm: Eastman Kodak Company
Product: KODAK DirectView DR 9000 System, Catalog Numbers 1966688 (US and Canada) and 8161937 (outside the US and Canada) --- A permanently installed diagnostic x-ray system composed of 3 main components: an operator console, U-Arm assembly with x-ray tube including a collimator, and a stationary generator.
Product code: KPR System, X-Ray, Stationary
Reason for recall: A control system failure may cause the U-Arm to move downward unexpectedly when the Radiology Technologist is positioning the equipment using the "Up" or "Down" control buttons. Downward movement occurs at three times the normal rate of speed and will continue until the device control button is released, the Emergency Stop button is activated or the equipment Bump Sensor contacts an object.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Urgent Medical Device Recall Letters (dated 5/29/2014) were sent to the consignees on 5/30/2014. Carestream Health recommends that the DR 9000 U-arm be moved before positioning the patient under the U-arm for a decubitus exam. This will remove any potential safety hazard posed to the patient as a result of any unexpected movement. For questions or concerns, please contact the Carestream Customer Care Center in the US at 1-800-328-2910, available 7 days per week on a 24 hour basis; Outside of the US, please call your local Service support number.
Quantity in commerce: Domestic: 100 units; Foreign: 46 units
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Canada, China, Italy, Germany, Greece, Kuwait, Spain, South Africa, and United Arab Emirates.
Product codes and lots: Service Code 1534

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2137-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2137-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-13	2014-08-01

Product code KPR

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)