KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream Health, Inc. Made in U.S.A.
FDA device recall Z-0844-2014 · posted 2014-01-27 · Terminated
Recall details
- Recalling firm
- Carestream Health, Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- KPR
- Quantity affected
- 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 Kor
- Date initiated
- 2013-12-26
- Date posted
- 2014-01-27
- Date terminated
- 2017-03-10
- Location
- Rochester, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345 (K051258) | Eastman Kodak Company | 2005-06-01 |