Recall Z-0132-2014— Carestream Health Inc.
Class II · Terminated
Class II FDA medical device recall by Carestream Health Inc., initiated 2013-06-19, terminated 2016-05-20. It names one FDA 510(k) clearance: K120062. Product: DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and 3) 1023423 (w/ parts warranty, US-only). The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas. Reason: Carestream Health Inc. is conducting a recall for the Column end Cover present on the DRX Revolution Mobile X-Ray System due to the cover dislodging from the column..
- Recalling firm
- Carestream Health Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-06-19
- Terminated
- 2016-05-20
- Firm location
- Rochester, NY, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and 3) 1023423 (w/ parts warranty, US-only). The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas
Reason for recall
Carestream Health Inc. is conducting a recall for the Column end Cover present on the DRX Revolution Mobile X-Ray System due to the cover dislodging from the column.
Data sourced from openFDA. This site is unofficial and independent of the FDA.