Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 14.3, 15.0.1, 15.1.
Summary
The FDA issued a Class II for Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 1 by CHANGE HEALTHCARE CANADA COMPANY. Reason: A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data entry can lead to inaccurate hemodynamic calculations,.
Details
Source
Device Recall
External ID
Z-0126-2025
Action Date
2024-10-23
Status
Ongoing
Category
device
Product Description
Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 14.3, 15.0.1, 15.1.
Lot/Code Info: UDI Numbers: (01)17540262100013(10)140100, (01)17540262100020(10)140101, (01)17540262100037(10)140200, (01)17540262100044(10)140300, (01)17540262100051(10)140302, (01)17540262100099(10)150000, (01)17540262100105(10)150001, (01)17540262100129(10)150100. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 14.3, 15.0.1, 15.1.
Quantity Affected: 221 systems
Reason for Recall
A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data entry can lead to inaccurate hemodynamic calculations, potentially resulting in misdiagnosis and inappropriate treatment. This issue occurs when the unit of measurement (UOM) for hemoglobin is configured in a way that differs from the users understanding.
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Canada, Germany, Ireland, Israel, United Kingdom.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-08-21
Company
Richmond
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 180 device recalls issued in the same week, part of 403 device-related FDA actions this month.
CHANGE HEALTHCARE CANADA COMPANY has 10 FDA actions in our database, including 8 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (CHANGE HEALTHCARE CANADA COMPANY) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does CHANGE HEALTHCARE CANADA COMPANY have FDA actions?
CHANGE HEALTHCARE CANADA COMPANY has 10 FDA actions in our database, including 8 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0126-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29