DRX-Revolution Mobile X-Ray System recall
DRX-Revolution Mobile X-Ray System; MODEL DRXR-1; Catalog # 1019397 (all other countries) and Catalog 1060177 (China only) -- COMMON/USUAL NAME…
Why was DRX-Revolution Mobile X-Ray System recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Numbers: Worldwide except China: 101 through 2623; China only: 800101 through 800482
- Product
- DRX-Revolution Mobile X-Ray System; MODEL DRXR-1; Catalog # 1019397 (all other countries) and Catalog 1060177 (China only) -- COMMON/USUAL NAME…
- Recalling firm
- Carestream Health Inc
- Quantity
- Domestic: 1449 units; Foreign: 1416 units
- Distribution
- Worldwide Distribution - US (nationwide) Internationally to Australia, Brazil, Canada, Chile, China, Colombia, Dominican Republic, India, Japan, Israel, Korea, Malaysia, Maldives, Mexico, New Zealand, Peru, Puerto Rico, Singapore, Switzerland, Taipei, Thailand, Turkey, and UAE.
- Recall date
- July 5, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)