Food, drugs, devices › GE Healthcare, LLC

Device recall: Centricity Universal Viewer with Cross Enterprise Display This impacts product versions 6.0 SP1 and higher.

FDA enforcement event 81297 · Class II · initiated 30 Aug 2018 · status Terminated · terminated 31 Aug 2022

DeviceVoluntary: Firm initiated1 product recordWaukesha, WI

GE Healthcare, LLC (Waukesha, WI) initiated this device recall on 30 Aug 2018; FDA lists 1 product record under event 81297, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.

Status: Terminated, terminated 31 Aug 2022. Initiation: voluntary: firm initiated. GE Healthcare, LLC has 225 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

GE Healthcare, LLC, Waukesha, WI.

Reason for recall

"Remote comparison studies displayed may be associated with the wrong patient, without a caution icon present."

Distribution

"NY"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0195-2019	Centricity Universal Viewer with Cross Enterprise Display This impacts product versions 6.0 SP1 and higher.	1	Class II	Terminated	24 Oct 2018

Context

92%of 2018 device events are Class II1,074 events that year

1product record in this eventfirm median: 1

225events on this register for the firm

Other enforcement events for GE Healthcare, LLC

Initiated	Product (first record)	Type	Class	Records
27 Feb 2026	SIGNA Premier systems	Device	Class II	1
15 Jul 2022	(1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3	Device	Class II	1
24 Jun 2022	SIGNA Premier magnetic resonance scanner, model 5748519.	Device	Class II	1
14 Jun 2022	Centricity PACS Software Version 7.0 SP0.0.4.7	Device	Class II	1
8 Jun 2022	GE Centricity Universal Viewer Zero Footprint. To view, communicate, process, and display Medical images and data within	Device	Class II	1
2 Jun 2022	Service manuals for the CT, PET, or NM table as follows: GT1700/GT1700V/VT1700, GT2000/VT2000, GT2000x/VT2000x, High Cap	Device	Class II	1
1 Jun 2022	GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia Syste	Device	Class I	1
27 May 2022	GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia Systems, Part	Device	Class II	1
10 May 2022	CARESCAPE Central Station (CSCS) V2, Model numbers 2082278-001 and 2082279-001. Update 3/10/2023: The following FRU and	Device	Class II	1
28 Apr 2022	Centricity Universal Viewer Zero Footprint Client	Device	Class II	5

All 225 events for GE Healthcare, LLC

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Remote comparison studies displayed may be associated with the wrong patient, without a caution icon present."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "NY"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 31 Aug 2022. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.