Skip to content

Change Healthcare Cardiology Hemo recallZ-2071-2025 · Change Healthcare Canada Company · initiated May 22, 2025

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 Change Healthcare Canada Company 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

Due to complaints, software update may cause software to unexpectedly shutdown.

FDA root cause category: Software design

What the company is doing

On May 22, 2025, Change Healthcare issued a "Urgent Field Safety notice" to affected consignees via e-mail. On May June 11, 2025, Change Healthcare sent out an updated notification providing additional information. Change Healthcare asked consignees to take the following actions: 1. Change Healthcare has developed a software update that addresses this issue. Contact Change Healthcare support to schedule its deployment. 2. This notice must be distributed to all personnel within your organization who need to be aware of this notice. Customers should alert other affiliated parties that may be affected by this notice. 3. 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.

Recall details

Recall number
Z-2071-2025
Status
Open, Classified
Initiated by the company
May 22, 2025
Posted by the FDA
Jul 2, 2025
Recalling firm
Change Healthcare Canada Company
Quantity
29 systems
Product code
MWI
FDA submissions
K131497
Distribution
Worldwide - US Nationwide distribution in the states of AL, AR, CA, FL, KY MO, MS, NE, NH, NJ, PA, TN, TX, WA and the countries of Australia, Canada, Germany, Great Britain, Ireland, Israel, New Zealand.

Product description

Change Healthcare Cardiology Hemo Software

Code information (models, lots, serial numbers)

Software version 14.3.2/UDI: (01)17540262100051/ 15.0.1/UDI: (01)17540262100105

Devices named in this recall

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

Product lines

Other devices under the same FDA submission

7 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 97046).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page