Recall StatusOpen, Classified
Date Initiated2021-04-19
Product Quantity33 devices
Reason for Recall
A software defect was identified where the Image Styles defined by presentation states from CHRS are not displayed in CHEV.
Firm Action
On 04/19/21 the firm sent a letter to its consignees with the following instructions:
Immediate actions to take to reduce the risk to patient
Prior to treating patients, always confirm the correct patient anatomy by reviewing the laterality markers applied during image acquisition.
When the issue is detected, the clinician is able to manually adjust the Image Styles in CHEV to accommodate their viewing requirements and/or orient images to standard anatomical position.
Product updates that will address the issue
Change Healthcare is developing a software update to correct image display of orientation, image inversion and window level information from Image Styles.
Recommended actions to take on potentially affected data
We strongly encourage customers receiving this Urgent Field Safety Notice to immediately contact Change Healthcare Customer Support to:
1) Acknowledge they have read and understood this Urgent Field Safety Notice; and,
2) Arrange the installation of software update.
Change Healthcare Customer Support: 1-800-663-2533 Menu Option 3 (CHEV)
Root Cause
Software design
Distribution Pattern
US Nationwide distribution in the states of AK, AR, AZ, CA, FL, HI, IA, IN, IL, KY, NE, NY, MA, MI, MS, OH, PA, TX,TN, WA, WI, WY.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.