CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a permanently installed diagnostic X-ray system for g
FDA device recall Z-2449-2015 · posted 2015-08-22 · Terminated
Recall details
- Recalling firm
- Carestream Health Inc
- Reason for recall
- Software defect that impacts image alignment when using the automatic stitching option for long length images. The defect could cause stitching inconsistencies which may go undetected on a radiograph.
- Action taken
- Carestream sent an Urgent Medical Device Correction letters dated July 29, 2015 and Customer Notification Acknowledgement Forms to customers via Certified Mail. The letter identified the affected product, problem and actions to be taken. Carestream will update the software on your device to correct this issue. For questions or concerns, contact the Carestream Customer Care Center in the U.S. at 1-800-328-2910, available 7 days per week on a 24 hour basis. Outside of the U.S., please call your local Service support number.
- Root cause
- Software design
- Status
- Terminated
- Product code
- KPR
- Quantity affected
- Domestic: 76 units, Foreign: 160 units
- Distribution
- Worldwide Distribution - US Nationwide and in the countries: Australia, Canada, Chile, China, India, Korea, Malaysia, New Zealand, Singapore, Switzerland, Taiwan and Thailand.
- Date initiated
- 2015-08-07
- Date posted
- 2015-08-22
- Date terminated
- 2016-07-06
- Location
- Rochester, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DRX-EVOLUTION (K141837) | Carestream Health, Inc. | 2015-03-11 |