FDAClass IIMarch 29, 2017

Merge Cardio software recall

Merge Cardio software.

Why was Merge Cardio software recalled?

Cardio study list does not show STAT studies without refreshing.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Versions 9.0; 9.0.1; 9.0.2; 9.0.3; 9.0.4; 9.0.5; 9.0.6; 9.0.7, 9.0.8, 9.0.9, 10.0, 10.0.1, 10.1, 10.1.1, and 10.1.2.

Product
Merge Cardio software.
Recalling firm
Merge Healthcare, Inc.
Quantity
217 sites potentially have the affected versions
Distribution
Distribution was nationwide to medical facilities. There was also military distribution. There was no foreign/government distribution.
Recall date
March 29, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls