Recall Z-0820-2015— Carestream Health, Inc.
Class II · Terminated
Class II FDA medical device recall by Carestream Health, Inc., initiated 2014-10-30, terminated 2017-03-10. It names 2 FDA 510(k) clearances: K020635, K923554. Product: CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer.. Reason: Reduced mammographic image quality when attempting to print true size multi-format images.
- Recalling firm
- Carestream Health, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-10-30
- Terminated
- 2017-03-10
- Firm location
- Rochester, NY, United States
510(k) clearances named in this recall
2 on FDA's record- K020635 — KODAK DIRECTVIEW CR 800 SYSTEM, CATALOG# 1268622; KODAK DIRECTVIEW CR 900 SYSTEM, CATALOG# 1170976
- K923554 — KODAK EKTASCAN
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
Reason for recall
Reduced mammographic image quality when attempting to print true size multi-format images
Data sourced from openFDA. This site is unofficial and independent of the FDA.