CLASS II Device recall · Reported 3 Aug 2022 · FDA Enforcement Report

Centricity PACS recalled by GE Healthcare

GE Healthcare is recalling Centricity PACS, distributed nationwide in the US. The recall was initiated on 14 Jun 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel: 5831882-012, Software Version 7.0 SP0.0.4.7 GTIN: 00840682145572

Quantity recalled47 installations

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-1466-2022
FDA event ID: 90525
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Terminated
Recall initiated: 14 Jun 2022
FDA classified: 25 Jul 2022
Reported: 3 Aug 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

14 Jun 2022	Recall initiated by company
25 Jul 2022	Classified by FDA	+41 days
3 Aug 2022	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

The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Centricity PACS Software Version 7.0 SP0.0.4.7

Where it was distributed

Worldwide distribution - US Nationwide distribution in the states of CO, NV, OH, PA, WA and the countries of Brazil, Canada, China, France, Germany, Israel, Italy, Japan, Oman, Spain, Switzerland, and United Kingdom.

Nationwide Colorado Nevada Ohio Pennsylvania Washington

Questions about this recall

Why was it recalled?

The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams.

Which lots are affected?

Model: 5831882-012, Software Version 7.0 SP0.0.4.7 GTIN: 00840682145572

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.

More recalls from GE Healthcare

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

Other Medical Software recalls

All 908

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	Volara System Volara, HC, NA recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	Enterprise Archive V8 recalled by GE Healthcare	GE Healthcare	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	Veriqa RT MonteCarlo 3D v3 recalled by PTW Freiburg	PTW Freiburg	Device Malfunction	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	Et Control recalled by Datex-Ohmeda	Datex-Ohmeda	Device Malfunction	Nationwide