iConnect Access used with Merge PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks.
Reported: August 24, 2016 Initiated: January 30, 2016 #Z-2531-2016
Product Description
iConnect Access used with Merge PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks.
Reason for Recall
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.
Details
- Recalling Firm
- Merge Healthcare, Inc.
- Units Affected
- 146 sites potentially have the affected versions 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.
- Location
- Hartland, WI
Frequently Asked Questions
What product was recalled? ▼
iConnect Access used with Merge PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks.. Recalled by Merge Healthcare, Inc.. Units affected: 146 sites potentially have the affected versions for both products.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 24, 2016. Severity: Moderate. Recall number: Z-2531-2016.
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