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Merge Cardio recallZ-1402-2025 · Merge Healthcare, Inc. · initiated Feb 19, 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 Merge Healthcare, Inc. 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

When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent with the associated primitive measurements in the final patient report.

FDA root cause category: Software design

What the company is doing

Merge Healthcare issued an Urgent Field Safety Notice to it's consignees on 02/19/2025 via email. The notice explained the issue, risk to patients, provided a workaround to immediately address the issue, and recommended clinicians check measurements in the final report to ensure that they accurately reflect the patient's condition pending software update. Required Actions: Merge Healthcare Support will contact all customers to: i) Confirm that you have read and understood this Urgent Field Safety Notice. ii) Schedule an update to implement the configuration change on your system. For more information, please contact Merge Healthcare Support at 1-877-741-5369 (available 24 hours a day, 7 days a week) or visit our website: https://www.merative.com/support/merge. Please forward this notice to any individuals within your organization that may need to be aware of this notification. Customers should alert any other affiliated parties that may be affected by this Urgent Field Safety Notice. The firm identified a missing software version (11.0.2) and issued the corrected notice on 03/03/2025.

Recall details

Recall number
Z-1402-2025
Status
Open, Classified
Initiated by the company
Feb 19, 2025
Posted by the FDA
Mar 20, 2025
Recalling firm
Merge Healthcare, Inc.
Quantity
253
Product code
LLZ
FDA submissions
K192206
Distribution
US

Product description

Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.1.1, 12.2, 12.3, 12.3.1, 12.3.2, 12.3.3, 12.4, 12.4.1, 12.4.2; Merge Cardio is a software medical device that is an integrated multi-modality image cardiovascular information management system.

Code information (models, lots, serial numbers)

Lot Code: Software versions and UDIs 12.4.1 UDI: (01)00842000101123(10)12.4.1(11)240522 12.4.2 UDI: (01)00842000101123(10)12.4.2(11)250206 12.1, UDI: (01)00842000100928(10)12.1(11)210122; 12.1.1, UDI: (01)00842000100928(10)12.1.1(11)211220; 12.2 UDI: (01)00842000100065(10)12.2.0(11)220713; 12.3, UDI: (01)00842000101109(10)12.3.0(11)221114; 12.3.1 UDI: (01)00842000101109(10)12.3.0(11)221114; 12.3.2 UDI: (01)00842000101109(10)12.3.2(11)230612; 12.3.3 UDI: (01)00842000101109(10)12.3.3(11)230913; 12.4 UDI: (01)00842000101123(10)12.4.0(11)231220; 12.4.1 UDI: (01)00842000101123(10)12.4.1(11)240522; 12.4.2 UDI: (01)00842000101123(10)12.4.2(11)250206

Devices named in this recall

4 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 K192206 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 96344).

Sources and updates

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