Recall Z-1773-2021— CHANGE HEALTHCARE CANADA COMPANY
Class II · Ongoing
Class II FDA medical device recall by CHANGE HEALTHCARE CANADA COMPANY, initiated 2021-04-19. It names one FDA 510(k) clearance: K181185. Product: Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D display of DICOM and non-DICOM medical images, reports, and multimedia content.. Reason: A software defect was identified where the Image Styles defined by presentation states from CHRS are not displayed in CHEV..
- Recalling firm
- CHANGE HEALTHCARE CANADA COMPANY
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-04-19
- Firm location
- Richmond, Canada
510(k) clearances named in this recall
1 on FDA's recordK-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
Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D display of DICOM and non-DICOM medical images, reports, and multimedia content.
Reason for recall
A software defect was identified where the Image Styles defined by presentation states from CHRS are not displayed in CHEV.
Data sourced from openFDA. This site is unofficial and independent of the FDA.