FDAFDA · Food and drugs·Recall number Z-0137-2017
CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI.
Published October 26, 2016 · Recall initiated: January 30, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The software was not presenting the PURE filter user interface message on DICOM transfer studies. If a site starts using PURE filter, the user interface message will not display. This may result in incorrect patient follow-up.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Merge Healthcare, Inc.
- Distributor
- Worldwide Distribution - USA (nationwide) Distribution. Foreign/military/government distribution was also made.
- Lot
- Versions prior to 5.2.9
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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