CLASS II Device recall · Reported 14 Nov 2018 · FDA Enforcement Report

Centricity Pacs-iw with Universal Viewer recalled by GE Healthcare

GE Healthcare is recalling Centricity Pacs-iw with Universal Viewer, distributed in 13 states. The recall was initiated on 11 Oct 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes102062-1-Centricity Universal Viewer-00558650/1-357058918; 102406-2-Centricity Universal Viewer-00558667/1-640193933; 102406-2-Centricity Universal Viewer-00558669/1-598891571; 102747-1-Centricity Universal Viewer-00558673 /1-626086029; 103246-1-Centricity Universal Viewer-00558668 / 1-681512983; 11580-1-Centricity Universal Viewer-00558646 / 1-417869653; 2403-7-Centricity Universal Viewer-00558347 1-283597082; 269338-Centricity Universal Viewer-01453050 /HCIT4331279PIW; 4284-1-Centricity Universal Viewer-00558672 / 1-308060186; 4424-2-Centricity Universal Viewer-01474435 / CONCORDIM01474435; Installation tracked via System ID. / HCIT4216808PIW; Installation tracked via System ID. / 2UA443117XAW; and X13479-Centricity Universal Viewer-00043936 / X1347906 / X1347909.

Quantity recalled13

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-0374-2019
FDA event ID: 81418
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Terminated
Recall initiated: 11 Oct 2018
FDA classified: 2 Nov 2018
Reported: 14 Nov 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

11 Oct 2018	Recall initiated by company
2 Nov 2018	Classified by FDA	+22 days
14 Nov 2018	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

Synchronization failure

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-IW with Universal Viewer version 5.0.x with PACS-IW foundation displays medical images (including mammograms) and data from various imaging sources.

Where it was distributed

CA, CO, DE, FL, HI, NY, OK, PA, SD, TX, WA, WI, and WV Belgium, Brazil, Canada, Colombia, France, Germany, Ghana, Ireland, Italy, Mexico, Netherlands, Panama, Poland, Saudi Arabia, South Africa, Spain, Switzerland, and Turkey.

California Colorado Delaware Florida Hawaii New York Oklahoma Pennsylvania South Dakota Texas Washington Wisconsin West Virginia

Questions about this recall

Why was it recalled?

Synchronization failure

Which lots are affected?

102062-1-Centricity Universal Viewer-00558650/1-357058918; 102406-2-Centricity Universal Viewer-00558667/1-640193933; 102406-2-Centricity Universal Viewer-00558669/1-598891571; 102747-1-Centricity Universal Viewer-00558673 /1-626086029; 103246-1-Centricity Universal Viewer-00558668 / 1-681512983; 11580-1-Centricity Universal Viewer-00558646 / 1-417869653; 2403-7-Centricity Universal Viewer-00558347 1-283597082; 269338-Centricity Universal Viewer-01453050 /HCIT4331279PIW; 4284-1-Centricity Universal Viewer-00558672 / 1-308060186; 4424-2-Centricity Universal Viewer-01474435 / CONCORDIM01474435; Installation tracked via System ID. / HCIT4216808PIW; Installation tracked via System ID. / 2UA443117XAW; and X13479-Centricity Universal Viewer-00043936 / X1347906 / X1347909.

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 81418

Reported	Class	Recall	Company	Reason	Where
14 Nov 2018	CLASS II	Centricity Universal Viewer recalled by GE Healthcare	GE Healthcare	Device Malfunction	13 states

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