Carestream DRX Evolution System, X-Ray System --- The DRX-Evolution system is a permanently installed diagnostic x-ray s

FDA device recall Z-1877-2013 · posted 2013-08-12 · Terminated

Recall details

Recalling firm

Carestream Health Inc.

Reason for recall

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

Action taken

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.

Root cause

Radiation Control for Health and Safety Act

Status

Terminated

Product code

KPR

Quantity affected

US: 49 units; Foreign: 183 units (revised)

Distribution

Worldwide Distribution - USA (nationwide) including the countries of Austria, Australia, Belgium, Canada, China, Finland, France, Germany, Italy, Korea, Kuwait, Saudi Arabia, Spain, Sweden, Switzerlan

Date initiated

2013-06-03

Date posted

2013-08-12

Date terminated

2014-01-29

Location

Rochester, NY

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