Merge PACS software. The firm name on the label is recall
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
Why was Merge PACS software. The firm name on the label is recalled?
Potential exists for an incorrect patient image being displayed which could result in the delay in diagnosis or treatment.
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?
Version 7.0.1
- Product
- Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
- Recalling firm
- Merge Healthcare, Inc.
- Quantity
- 29 sites have the potentially affected software
- Distribution
- Distribution was made to medical facilities in AZ, CA, CO, FL, HI, IL, MA, MD, MI, MO, NY, OH, PA, SC, TN, UT, and WI. There was no foreign/government/military distribution.
- Recall date
- February 15, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)