KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream Health, Inc. Made in U.S.A.
FDA Recall Z-0844-2014 · Posted 2014-01-27
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Recalling FirmCarestream Health, Inc.
Recall StatusTerminated
Product CodeKPR
Date Initiated2013-12-26
Date Terminated2017-03-10
Product Quantity164 units Total (42 domestically & 122 internationally)
Reason for Recall
Carestream Health, Inc. has recalled DR 7500 Dual Detector System utilizing Version 5.X Software due to a possible patient image display error.
Firm Action
On December 26, 2013 Carestream Health, Inc. distributed Urgent Medical Device Recall notification letters dated December 19, 2013 to their customers via Fed Ex. Carestream Health, Inc. recommends that once the daily detector calibration process is initiated on the DR 7500 System running Version 5.X software it should not be interrupted. The calibration process should be completed only when patients are not being imaged. A Carestream Health Service representative will contact all customers to install a software modiciation to Version 5.X software which will not allow the cancellation of detector calibration. Customers will questions can call 1-800-328-2910 7 days per week on a 24 hour basis.
Root Cause
Software Manufacturing/Software Deployment
Distribution Pattern
worldwide Distribution - US (Nationwide) including states of: IN, PA, MD, MI, NY, GA, MN, OK, VA, TX, WI, CA, IL, TN, WA, NC, SC, MA, NJ, and KY; and Internationally to: Canada, New Zealand, South Korea, Australia, Hong Kong, Saudia Arabia, Guinea, Kuwait, Israel, Oman, South Africa, China, UK, Sweden, Poland, Denmark, Germany, Finland, Czech Republic, Italy, France, Portugal and Spain.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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