Carestream Health, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0820-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer.

Product Classification:

Class II

Date Initiated: October 30, 2014

Date Posted: December 24, 2014

Recall Number: Z-0820-2015

Event ID: 69703

Reason for Recall:

Reduced mammographic image quality when attempting to print true size multi-format images

Status: Terminated

Product Quantity: 59 units

Code Information:

Software Verions: 1) 5.7.312.27 , 2) 5.7.312.27, 3) 5.7.312.2031

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated