Recall Z-2651-2017— Carestream Health Inc
Class II · Terminated
Class II FDA medical device recall by Carestream Health Inc, initiated 2017-05-25, terminated 2018-06-13. It names one FDA 510(k) clearance: K120062. Product: DRX-Revolution Mobile X-Ray System; MODEL DRXR-1; Catalog # 1019397 (all other countries) and Catalog 1060177 (China only) -- COMMON/USUAL NAME: DRX-Revolution --- The DRX-Revolution is a mobile system used to generate and control X-Rays for diagnostic procedures. Reason: Carestream found a single unit where four screws in the assembly were not applied in the manufacturing process. This could result in separation of the tube and yoke assembly..
- Recalling firm
- Carestream Health Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-05-25
- 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
DRX-Revolution Mobile X-Ray System; MODEL DRXR-1; Catalog # 1019397 (all other countries) and Catalog 1060177 (China only) -- COMMON/USUAL NAME: DRX-Revolution --- The DRX-Revolution is a mobile system used to generate and control X-Rays for diagnostic procedures
Reason for recall
Carestream found a single unit where four screws in the assembly were not applied in the manufacturing process. This could result in separation of the tube and yoke assembly.
Data sourced from openFDA. This site is unofficial and independent of the FDA.