Fresh Recalls

FDAClass II · Medical device · Recall Z-2875-2026 · Recalled August 12, 2026

Merge OrthoPACS recall — Merge Healthcare, Inc.

Agency report date: August 12, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named
Merge OrthoPACS
Company / brand
Merge Healthcare
Lot / serial / date codes
UDI/DI (01)00842000101154(10)9.4.0.P02(11)260302, with Affected Versions: 9.4, 9.4 P01, and 9.4 P02.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, and UK.
Agency product description and boundaries

Merge OrthoPACS, medical imaging diagnostic workstation

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

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No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: Merge OrthoPACS

3. Open the official notice or contact

Official recall ID
Z-2875-2026
Brand
Merge Healthcare
Classification
Class II
Units affected
5 units
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Affected products

Companies & origin

Recalling firm location
Hartland, WI, United States
Firm address
900 Walnut Ridge Dr, 53029-8347

Identifying details (verbatim from the notice)

Product codes / lots
UDI/DI (01)00842000101154(10)9.4.0.P02(11)260302, with Affected Versions: 9.4, 9.4 P01, and 9.4 P02.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, and UK.
Firm notified the public via
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
FDA event ID
99391
Recall initiated
June 30, 2026
FDA classified
August 4, 2026
FDA report date
August 12, 2026
Verify with the official sources:

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked September 7, 2026 at 6:00 AM UTC. Record retrieved September 7, 2026 at 6:00 AM UTC.

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