FDA Medical Device Recalls (openFDA)
Merge Healthcare, Inc.: Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
- Recall number
- Z-3004-2026
- Recalling firm
- Merge Healthcare, Inc.
- Product
- Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
- Status
- Open, Classified
- Initiated
- 2026-07-22
- Posted
- 2026-08-21
- Terminated
- not on file
- Reason
- Software issue may cause measurements to be displayed inaccurately.
- Root cause
- Software Design Change
- Action
- Merge Healthcare issued an Urgent Field Safety Notice to its consignees on 7/22/2026 via email with a follow-up telephone call. The notice explained the issue and how to identify it, risk to patient, and requested the following: "Immediate actions to reduce risk to patients Merge Healthcare recommends that customers contact Merge Healthcare Support to identify any affected ultrasound studies and the necessary next steps to be taken. Until the software update is installed, ultrasound measurements performed using the Merge PACS & OrthoPACS Viewer should be confirmed against the measurements acquired at the ultrasound modality." The required actions are as follows: "Merge Healthcare Support will contact all customers to: i) Confirm that you have read and understood this Urgent Field Safety Notice. ii) Assist you in identifying and reviewing any ultrasound studies with measurements that may have been affected. iii) Schedule the installation of the software update that eliminates the root cause of this issue. Please forward this notice to any individuals within the organization that may need to be aware of this notification. Customers should alert any other affiliated parties that may be affected by this Urgent Field Safety Notice. For more information, please contact Merge Healthcare Support at 1-877-741-5369 (available 24 hours a day, 7 days a week) or visit our website: https://www.merative.com/support/merge.
- Quantity
- 20 units
- Distribution
- US Nationwide distribution in the states of California, Florida, Kentucky, Nebraska, Washington.
- Lot, serial or model codes
- Software version V9.5 - UDI (01)00842000101239(10)9.5.0(11)260409
- 510(k) numbers
- ["K192455"]
- 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