Merge Cardio software. The firm name on the label is recall
Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to be used to acquire, store, print, transfer, and…
Why was Merge Cardio software. The firm name on the label is recalled?
Fetal patient report was automatically pulling prior measurement data for a prior fetus since the fetal study is based on the mother's MRN, resulting in the wrong fetal measurements getting referenced.
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 10.0, 10.0.1, 10.1, 10.1.1,10.1.1.1, and 10.1.2.
- Product
- Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to be used to acquire, store, print, transfer, and…
- Recalling firm
- Merge Healthcare, Inc.
- Quantity
- 30 sites have the potentially affected software versions
- Distribution
- Distributed to the states of AZ, CT, FL, GA, IL, IN, LA, MI, NY, NC, OH, OK, TX, and VT.
- Recall date
- May 31, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)