CLASS II ONGOING Device recall · Reported 2 Sep 2026 · FDA Enforcement Report
Merge PACS and Merge OrthoPACS recalled by Merge Healthcare
Merge Healthcare is recalling Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation, distributed nationwide in the US. The recall was initiated on 22 Jul 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3004-2026
- FDA event ID
- 99520
- Recalling firm
- Merge Healthcare, Hartland, WI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Jul 2026
- FDA classified
- 21 Aug 2026
- Reported
- 2 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Labeling Errors
- Device type
- Imaging Equipment
Timeline
| 22 Jul 2026 | Recall initiated by company | |
| 21 Aug 2026 | Classified by FDA | +30 days |
| 2 Sep 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Software issue may cause measurements to be displayed inaccurately.
Product as listed by the FDA
Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
Where it was distributed
US Nationwide distribution in the states of California, Florida, Kentucky, Nebraska, Washington.
Questions about this recall
Why was it recalled?
Software issue may cause measurements to be displayed inaccurately.
Which lots are affected?
Software version V9.5 - UDI (01)00842000101239(10)9.5.0(11)260409
Where was it sold?
US Nationwide distribution in the states of California, Florida, Kentucky, Nebraska, Washington.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Merge Healthcare
All 96| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Merge OrthoPACS, medical imaging diagnostic workstation recalled | Merge Healthcare | Other | Nationwide |
| Device | CLASS II | Merge PACS, medical imaging diagnostic workstation recalled | Merge Healthcare | Other | Nationwide |
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