FDA Medical Device Recalls (openFDA)
Merge Healthcare, Inc.: CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI.
- Recall number
- Z-0137-2017
- Recalling firm
- Merge Healthcare, Inc.
- Product
- CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI.
- Status
- Terminated
- Initiated
- 2016-01-30
- Posted
- not on file
- Terminated
- 2020-10-05
- Reason
- 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.
- Root cause
- Software design
- 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 support@merge.com.
- Quantity
- 844 sites potentially have the affected versions
- Distribution
- Worldwide Distribution - USA (nationwide) Distribution. Foreign/military/government distribution was also made.
- Lot, serial or model codes
- Versions prior to 5.2.9
- 510(k) numbers
- ["K092954"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 1000116130
- Firm city
- Hartland
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28