Carestream DRX-Revolution Mobile X-Ray System Recalled for Brake Failure
Carestream Health is recalling DRX-Revolution Mobile X-Ray Systems because a complaint alleged the unit could not be stopped when applying the brake, resulting in a crash into an elevator.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural/mechanical defect (brake failure) that resulted in a crash, meeting the criteria for 'Severe' severity due to significant injury/property-damage reports.
Plain-English summary
Carestream Health, Inc. is recalling the DRX-Revolution Mobile X-Ray System, Model DRXR-1. The recall involves 1,403 units in the United States and 1,370 units in foreign countries. The affected units are identified by serial numbers 101 to 2545 (worldwide except China) and 800101 to 800468 (China only).
The recall was initiated after the firm received a complaint alleging that a DRX Revolution System could not be stopped when applying the brake. According to the complaint, the Revolution crashed into an elevator. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Consumers and healthcare facilities should contact Carestream Health, Inc. for further information regarding the recall and corrective actions. The company is located at 150 Verona Street, Rochester, NY 14608.
The recalled product
- 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
- Manufacturer
- Carestream Health Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Serial Numbers: 101 to 2545 (Worldwide except China)
- 800101 to 800468 (China only)
Distribution
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