Fresh Recalls

Merge PACS: recall status

Notice names this product. Merge Healthcare’s Merge PACS is named in FDA Class II recall Z-2874-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open. Identifying details: 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.. Units affected: 53 units. Status: Ongoing.

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 PACS
Company / brand
Merge Healthcare
Lot / serial / date codes
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
Worldwide distribution - US Nationwide and the countries of Canada, and UK.
Agency product description and boundaries

Merge PACS, 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.

Brand
Merge Healthcare

Recalls naming this model

FDA Class II · Medical device · August 12, 2026

Merge PACS recall — Merge Healthcare, Inc.

Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open.

Company / brand: Merge Healthcare

Affected product: Merge PACS

Official ID Z-2874-2026 · Official record ↗

See all Merge Healthcare recalls →

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Compiled from connected official public-domain government data. Sources last checked September 7, 2026 at 6:00 AM UTC.