CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
- Company
- Carestream Health, Inc.
- Recall Initiated
- October 30, 2014
- Posted
- December 17, 2014
- Terminated
- March 10, 2017
- Recall Number
- Z-0820-2015
- Quantity
- 59 units
- Firm Location
- Rochester, NY
Reason for Recall
Reduced mammographic image quality when attempting to print true size multi-format images
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, Taiwan, and Thailand.
Lot / Code Info
Software Verions: 1) 5.7.312.27 , 2) 5.7.312.27, 3) 5.7.312.2031
Root Cause
Software design
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.