Z-0806-2020 Class II Terminated
FDA device recall Z-0806-2020 was initiated by Carestream Health, Inc. on January 6, 2020 and is designated Class II. Reason for recall: Carestream Health has discovered a potential safety problem that can lead to unintended movement of the U-Arm. The recall status is terminated (terminated May 29, 2020). Affected quantity: 79.
Recall Details
- Product Type
- Devices
- Report Date
- January 22, 2020
- Initiation Date
- January 6, 2020
- Termination Date
- May 29, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 79
Product Description
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.
Reason for Recall
Carestream Health has discovered a potential safety problem that can lead to unintended movement of the U-Arm.
Distribution Pattern
Worldwide distribution in the sate of Iowa and countries of Italy, China, Spain, and Austria.
Code Information
DR3000: 6551360, 6551386, 6551345, 6552160, 6552152, 6551394 DR3500: 6553101, 6553127, 6553119, 6553143, 6553135, 6553036, 6553093