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Change Healthcare Cardiology Hemo software recallZ-0958-2025 · A L I Technologies Ltd · initiated Dec 2, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from A L I Technologies Ltd or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).

FDA root cause category: Software design

What the company 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.

Recall details

Recall number
Z-0958-2025
Status
Open, Classified
Initiated by the company
Dec 2, 2024
Posted by the FDA
Jan 16, 2025
Recalling firm
A L I Technologies Ltd
Quantity
204 units
Product code
MWI
FDA submissions
K131497
Distribution
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.

Product description

Change Healthcare Cardiology Hemo software

Code information (models, lots, serial numbers)

Software version/UDI: 14.1.1/(01)17540262100020, 14.2/(01)17540262100037, 14.3/(01)17540262100044, 14.3.2/(01)17540262100051, 15.01/(01)17540262100105, 15.1/(01)17540262100129

Devices named in this recall

6 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

3 devices cleared under K131497 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 96025).

Sources and updates

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