Device Recall Carestream DRX Evolution System 의 리콜

Recall

65369

Class 2

Z-1877-2013

2013-06-03

2013-08-12

Terminated

United States

2014-01-29

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118683

Due to potential for an x-ray exposure technique change.

Carestream will make the correction which includes the installation of a SW patch to the affected customer sites, and to any other affected customer sites utilizing the DRX Evolution with V5. 5 SW outside of the US. --- Once receiving FDA approval on the corrective action plan, the correction will be implemented to all affected devices at identified customer sites: 1. A notification letter was sent to all customers identifying the issue and highlighting the approved procedures of the Corrective Action Plan. The letters were sent on 8/16/13 via Certified Mail, Return Receipt Requested. 2. Carestream Health will contact the customer to schedule a service visit to install software updates to correct this issue. The installation time will be approximately one hour. 3. As stated in the customer notification letter, this software update will be provided to the customer at no expense. 4. All software updates are estimated to be completed within 1-3 months. 5. Carestream Health will provide monthly progress reports on the effectiveness of the plan, including the number of units corrected. Further questions please call (800) 328-2910.