CLASS II ONGOING Device recall · Reported 1 Nov 2023 · FDA Enforcement Report

Universal Viewer Workflow Manager recalled by GE Healthcare

GE Healthcare is recalling Universal Viewer Workflow Manager, Image processing radiological system, distributed nationwide in the US. The recall was initiated on 8 Sep 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/DI 00195278379610, Software versions 7.0 SP1.1, 7.0 SP1, 7.0 SP0.0.5, 7.0 SP0.1.0. All product IDs with an affected software version are impacted.

Quantity recalled57 units

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-0143-2024
FDA event ID: 93053
Recalling firm: GE Healthcare, Chicago, IL
Classification: Class II
Status: Ongoing
Recall initiated: 8 Sep 2023
FDA classified: 23 Oct 2023
Reported: 1 Nov 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

8 Sep 2023	Recall initiated by company
23 Oct 2023	Classified by FDA	+45 days
1 Nov 2023	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a third-party reporting application is used to launch exams, it could display information on a different patient than WFM and the Viewer.

Product as listed by the FDA

Universal Viewer Workflow Manager, Image processing radiological system

Where it was distributed

Nationwide distribution to AR, AZ, CA, CO, DE, FL, GA, IL, IN, ME, MI, MN, MO, NE, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX. International distribution to Austria, Canada, France, Germany, Hong Kong, Israel, Italy, Philippines, Singapore, Thailand, Turkey, Vietnam.

Nationwide Arkansas Arizona California Colorado Delaware Florida Georgia Illinois Indiana Maine Michigan Minnesota Missouri Nebraska New Jersey New Mexico Nevada New York Ohio Oklahoma

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI/DI 00195278379610, Software versions 7.0 SP1.1, 7.0 SP1, 7.0 SP0.0.5, 7.0 SP0.1.0. All product IDs with an affected software version are impacted.

Where was it sold?

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.

Other products in this recall event

1 other product · FDA event 93053

Reported	Class	Recall	Company	Reason	Where
1 Nov 2023	CLASS II	Centricity Universal Viewer Workflow Manager recalled by GE Healthcare	GE Healthcare	Other	Nationwide

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All 518

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS II	Enterprise Archive V8 recalled by GE Healthcare	GE Healthcare	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	Workflow Core Services V8, intended to provide set recalled	GE Healthcare	Other	Nationwide
23 Sep 2026Device	CLASS II	Core Services Hub V8, a set of backend services including recalled	GE Healthcare	Other	Nationwide
23 Sep 2026Device	CLASS II	Centricity Enterprise Archive V2, V3, and V4 recalled by GE Healthcare	GE Healthcare	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	Centricity PACS V2, V3, V4, V6, V7 recalled by GE Healthcare	GE Healthcare	Device Malfunction	Nationwide

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