FDA Medical Device Recalls (openFDA)
Carestream Health, Inc.: KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream Health, Inc. Made in U.S.A.
- Recall number
- Z-0844-2014
- Recalling firm
- Carestream Health, Inc.
- Product
- KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream Health, Inc. Made in U.S.A.
- Status
- Terminated
- Initiated
- 2013-12-26
- Posted
- 2014-01-27
- Terminated
- 2017-03-10
- Reason
- Carestream Health, Inc. has recalled DR 7500 Dual Detector System utilizing Version 5.X Software due to a possible patient image display error.
- Root cause
- Software Manufacturing/Software Deployment
- 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.
- Quantity
- 164 units Total (42 domestically & 122 internationally)
- Distribution
- 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, serial or model codes
- Service Code: 8087; Catalog numbers: 8791345, 1155118, 1295088, 8551046, 8791345, 1666700, 8531675
- 510(k) numbers
- ["K051258"]
- PMA numbers
- not on file
- Product code
- KPR
- Firm FEI
- 1317307
- Firm city
- Rochester
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28