DRX-Revolution Mobile X-Ray System; MODEL DRXR-1; Catalog # 1019397 (all other countries) and Catalog 1060177 (China onl
FDA device recall Z-2651-2017 · posted 2017-06-19 · Terminated
Recall details
- Recalling firm
- Carestream Health Inc
- 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.
- Action taken
- Carestream Health sent the URGENT MEDICAL DEVICE CORRECTION Letters and Response Forms to the US consignees on May 25, 2017, via Certified Mail, Certified Receipt Requested. Letters to foreign accounts were distributed via e-mail or courier about the same time. Customers with questions were instructed to call 1-800-328-2910.
- Root cause
- Process control
- Status
- Terminated
- Product code
- IZL
- Quantity affected
- 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,
- Date initiated
- 2017-05-25
- Date posted
- 2017-06-19
- Date terminated
- 2018-06-13
- Location
- Rochester, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DRX-REVOLUTION MOBILE X-RAY SYSTEM (K120062) | Carestream Health, Inc. | 2012-04-13 |