Recall Z-1138-2017— Carestream Health Inc
Class II · Terminated
Class II FDA medical device recall by Carestream Health Inc, initiated 2017-01-12, terminated 2018-06-13. It names one FDA 510(k) clearance: K120062. Product: Carestream DRX-Revolution Mobile X-Ray System, Model DRXR-1, Catalog No. 1019397 (all other countries), Catalog No. 1060177 (China only) -- Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608. Reason: The firm received a complaint alleging that a DRX Revolution System could not be stopped when applying the brake. The Revolution crashed into an elevator..
- Recalling firm
- Carestream Health Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-01-12
- Terminated
- 2018-06-13
- 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
Carestream DRX-Revolution Mobile X-Ray System, Model DRXR-1, Catalog No. 1019397 (all other countries), Catalog No. 1060177 (China only) -- Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608
Reason for recall
The firm received a complaint alleging that a DRX Revolution System could not be stopped when applying the brake. The Revolution crashed into an elevator.
Data sourced from openFDA. This site is unofficial and independent of the FDA.