CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI.
FDA Recall Z-0137-2017 · Posted None
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Recalling FirmMerge Healthcare, Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2016-01-30
Date Terminated2020-10-05
Product Quantity844 sites potentially have the affected versions
Reason for Recall
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.
Firm Action
Merge Healthcare Inc. sent an Urgent Medical Device Recall letter dated January 28, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. In addition, the customer is requested to call Customer Service or send them an email to schedule the upgrade. If the customer chooses not to upgrade, they are requested to complete the attached form or go online and complete it.
Merge Healthcare is committed to improve efficiencies and enhancing the quality of healthcare worldwide.If you have any additional questions, call Merge Customer Service at (877) 741-5369 or [email protected].
Root Cause
Software design
Distribution Pattern
Worldwide Distribution - USA (nationwide) Distribution. Foreign/military/government distribution was also made.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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