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Merge PACS and Merge OrthoPACS
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MEDICAL DEVICE RECALLMODERATE

Merge PACS and Merge OrthoPACS

Merge PACS and OrthoPACS recalled due to inaccurate measurement display.

What to do

Contact Merge Healthcare, Inc. for software update instructions to correct the measurement display issue.

Recalled
Listed
Updated
Recall No.
Z-3004-2026
Agency
FDA
Firm
Merge Healthcare, Inc.
Recall ID
99520
Status
ONGOING

Recall at a glance

Quantity recalled
20 units

Why it was recalled

Merge Healthcare, Inc. is recalling Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstations, because a software issue may cause measurements to be displayed inaccurately.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation

UDI-DI
00842000101239

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Other Software Defect recalls

Other recent recalls from Merge Healthcare, Inc.

All recalls from Merge Healthcare, Inc.

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Editorial summary by Recall Canary · summary updated 2026-08-23 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification