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Recall Observatory FDA recall evidence

Device product

KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream Health, Inc. Made in U.S.A.

Z-0844-2014

December 26, 2013

Class II

Product summary

Firm
Carestream Health, Inc.
Event
Event 67188
Status
Terminated
Classification
Class II
Quantity
164 units Total (42 domestically & 122 internationally)
Official record key
device-enforcement:Z-0844-2014

Official wording

Reason: Carestream Health, Inc. has recalled DR 7500 Dual Detector System utilizing Version 5.X Software due to a possible patient image display error.

Code information: Service Code: 8087; Catalog numbers: 8791345, 1155118, 1295088, 8551046, 8791345, 1666700, 8531675

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.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    Software due to a possible patient image display error