A L I Technologies Ltd recalls Change Healthcare Cardiology Hemo software
Reason for recall
Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- Change Healthcare Cardiology Hemo softwareUDI 14.1.1/
What the firm is doing
On December 2, 2024 Change Healthcare Canada Company issued a "Urgent Field Safety" Recall Notice to affected consignees. Change Healthcare Canada Company ask consignees to take the following actions: 1. Please contact and work with our Customer Support team to identify and correct any potentially affected data. 2. This notice must be distributed to all personnel within your organization who need to be aware of this Urgent Field Safety Notice. Customers should alert other affiliated parties that may be affected by this Urgent Field Safety Notice. 3. To ensure effectiveness of any required corrective actions, please maintain awareness of this Urgent Field Safety Notice until the issue has been fully resolved. 4. Please notify our Customer Support department that you have read and understood this field safety notice, and if you want the product update to be installed on your system. Customer Support number by region: US / Canada: 1 877 654 4366 5. Once again, until the product update is installed at your site, Change Healthcare recommends that the immediate actions (described above) be taken.
DistributionShow detailsHide
US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, PA, SC, SD, TN, TX, WA, WI and the countries of Australia, Israel, Canada, Germany, Ireland, United Kingdom.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-0958-2025
- FDA 510(k) clearance · K131497The device's official FDA premarket clearance record
- FDA device classification · MWIOfficial FDA classification for this device type
- CFR regulation · 21 CFR 870.2300The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find A L I Technologies LtdSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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