Recall Z-0820-2015 ยท LLZ System, Image Processing, Radiological
Carestream Health, Inc.
CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
| Date | Dec 17, 2014 (initiated Oct 30, 2014) |
| Status | Terminated |
| Reason | Reduced mammographic image quality when attempting to print true size multi-format images |
| Root cause | Software design |
| Action | 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 so |
| Quantity | 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, Taiwan, and Thailand. |
| FDA record | Open on fda.gov |