iConnect Access used with Ortho PACS software provides recall
iConnect Access used with Ortho PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of…
Why was iConnect Access used with Ortho PACS software provides recalled?
Studies that are viewed in iConnect Access that originate on Merge PACS / Ortho PACS may not display the correct current patient demographics if there has been a PDE (Patient / Study Demographic Edit) performed after the images were ingested in PACS.
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?
iConnect Access V4.0 or earlier with any version of Ortho PACS and iConnect Access V4.1 with Ortho PACS V5.1.2 and earlier.
- Product
- iConnect Access used with Ortho PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of…
- Recalling firm
- Merge Healthcare, Inc.
- Quantity
- 146 sites may have the affected version for both products
- Distribution
- Distribution was made to medical facilities nationwide and to one foreign medical facility in New Zealand. There was no military or government distribution.
- Recall date
- August 24, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)