FDAFDA · Food and drugs·Recall number Z-0844-2014
KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream Health, Inc. Made in U.S.A.
Published February 5, 2014 · Recall initiated: December 26, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Carestream Health, Inc. has recalled DR 7500 Dual Detector System utilizing Version 5.X Software due to a possible patient image display error.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Carestream Health, Inc.
- Distributor
- 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.
- Lot
- Service Code: 8087; Catalog numbers: 8791345, 1155118, 1295088, 8551046, 8791345, 1666700, 8531675
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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