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

FDA device recall Z-2137-2014 · posted 2014-08-01 · Terminated

Recall details

Recalling firm

Carestream Health Inc.

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

KPR

Quantity affected

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.

Date initiated

2014-05-30

Date posted

2014-08-01

Date terminated

2014-12-17

Location

Rochester, NY