CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of
FDA device recall Z-0820-2015 · posted 2014-12-17 · Terminated
Recall details
- Recalling firm
- Carestream Health, Inc.
- Reason for recall
- Reduced mammographic image quality when attempting to print true size multi-format images
- Action taken
- The firm, Carestream Health Inc., sent an "URGENT: Medical Device Recall" notice dated October 28, 2014 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to use the one-up printing option rather the multi-format printing option if a hard copy is required. Carestream has a software update that will address this issue. A Carestream service representative will contact all customers to schedule a visit to correct this software issue. If you have any questions or concerns or would like to request the installation of the previous software version that does not have this issue, please contact the Carestream Customer Care Center in the U.S. at 1-800-328-2910, available 7 days per week on a 24 hour basis. Outside of the U.S. please call your local service support number.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 59 units
- Distribution
- Worldwide Distribution: US distribution to states of : NY, OH, and NC; and countries of: Argentina, Brazil, China, Chile, Colombia, France, Greece, Hong Kong, India, Japan, Korea, Mexico, Peru, Spain,
- Date initiated
- 2014-10-30
- Date posted
- 2014-12-17
- Date terminated
- 2017-03-10
- Location
- Rochester, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| KODAK DIRECTVIEW CR 800 SYSTEM, CATALOG# 1268622; KODAK DIRECTVIEW CR 900 SYSTEM, CATALOG# 1170976 (K020635) | Eastman Kodak Company | 2002-03-21 |
| KODAK EKTASCAN (K923554) | Eastman Kodak Company | 1993-02-12 |