Medical Device Recall: Z-0030-2026

FDA Recalls dataset · Firm: CHANGE HEALTHCARE CANADA COMPANY · Status: Open, Classified

Recall Action Class: N/A Date Initiated: 2025-08-13 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0030-2026.

Recall Res Number
Z-0030-2026
Recalling Firm / Manufacturer
FEI Number
3003757840
Recall Status
Open, Classified
Recall Classification
N/A
Date Initiated
2025-08-13
Date Posted
2025-10-02
Date Terminated
N/A
Product Code
LLZ
Event Number
97545
Product Quantity
12 programs
Product Description Change Healthcare Radiology Solutions software version 14.2.2

Reason for Recall Due to software issue, radiology reports may not be fully displayed when viewing.

Action Details On August 13, 2025, Change Healthcare Canada Company issued a Urgent Medical Device Recall notification to affected consignees via Email. Chang Healthcare asked consignees to take the following actions: 1. Generate an audit report to list all studies accessed since CHRS 14.2.2 client was first installed. 2. Re-evaluate the identified cases and take any necessary follow-up measures to confirm that each patient s diagnosis and management remain appropriate. 4. This notice must be distributed to all personnel within your organization who need to be aware 5. To ensure effectiveness of any required corrective actions, please maintain awareness of this RECALL until the issue has been fully resolved. 6. Please notify our Customer Support department at: 1-800-663-2533 that you have read and understood the recall notice and schedule your product update to be installed on your system.

Distribution Pattern Worldwide - US Nationwide distribution in the states of AR, WI, NJ, IN, AL, CA, WA, FL, MA, LA and the country of Canada.

Code Information / Serial Numbers Version 14.2.2/UDI: (01)17540262030068

Related Establishments / Registrations

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This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

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