Merge Cardio with software version 10.1 LA recall: Software Issue
Merge Cardio with software version 10.1 LA.
Why was Merge Cardio with software version 10.1 LA recalled?
The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customers before the product was completely validated in house.
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?
Merge Cardio with software version 10.1 LA. Merge Cardio is intended to allow users to review diagnostic and non-diagnostic quality images.
- Product
- Merge Cardio with software version 10.1 LA.
- Recalling firm
- Merge Healthcare, Inc.
- Quantity
- 1
- Distribution
- Distributed in the states of IL, NC, and VT.
- Recall date
- January 6, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)