The Recall Desk
HighFDA (Devices)·Z-2874-2026·Announced 2026-08-12

Merge PACS Medical Imaging Workstation Recalled Due to Patient Data Display Error

Merge Healthcare is recalling 53 Merge PACS medical imaging workstations due to a software issue where thumbnails from one patient's study may incorrectly display when viewing a different patient's study, potentially compromising patient confidentiality.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with risk-of-harm potential for patient data confidentiality breach and misdiagnosis, but no reported injuries or hospitalizations. Per rubric, risk-of-harm products without reported injury qualify as High severity.

Plain-English summary

Merge Healthcare, Inc. is recalling 53 Merge PACS medical imaging diagnostic workstations worldwide due to a software defect. The affected units run versions 9.4, 9.4 P01, and 9.4 P02. The hazard occurs when thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open. This could result in patient data confidentiality breaches and potential misdiagnosis if clinicians view incorrect patient images. No deaths, hospitalizations, or injuries have been reported in connection with this issue. Consumers should immediately stop using the affected devices and contact Merge Healthcare for repair or replacement instructions.

The recalled product

Product
Merge PACS, medical imaging diagnostic workstation
Manufacturer
Merge Healthcare, Inc.
Category
Medical Device — Medical Imaging Software
Hazard
Affected units
53

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • UDI (01)00842000101215(10)9.4.0.P01(11)250916
  • (01)00842000101154(10)9.4.0.P02(11)260302 with Affected Versions: 9.4
  • 9.4 P01
  • and 9.4 P02.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Merge Healthcare, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Merge Healthcare, Inc.

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