Recall Register

Food, drugs, devices › Ge Healthcare It

Device recall: Centricity PACS System versions 3.X and higher and 4.X and higher Product Usage: The Centricity PACS Workstation is inte

FDA enforcement event 64724 · Class II · initiated 15 Sep 2012 · status Terminated · terminated 10 Jun 2016

DeviceVoluntary: Firm initiated1 product recordBarrington, IL

Ge Healthcare It (Barrington, IL) initiated this device recall on 15 Sep 2012; FDA lists 1 product record under event 64724, 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. 88% of the 823 device enforcement events initiated in 2012 carry the same class.

Status: Terminated, terminated 10 Jun 2016. Initiation: voluntary: firm initiated. Ge Healthcare It has 17 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 It, Barrington, IL.

Reason for recall

"There is a potential loss of image(s) associated with the Centricity to Centricity (C2C) exam transfer module of Centricity PACS System versions 3.X and higher and 4.X and higher when transferring from the source to a destination server. When another process in the destination server attempts to access the same object or table, the transfer process of a particular image may be terminated. Once ter"

Distribution

"Worldwide Distribution - US: Nationwide (AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN,…"

Product records

Recall numberProductQuantityClassStatusReport date
Z-0731-2014Centricity PACS System versions 3.X and higher and 4.X and higher Product Usage: The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also…748 unitsClass IITerminated22 Jan 2014

Context

88%of 2012 device events are Class II823 events that year
1product record in this eventfirm median: 1
17events on this register for the firm

Other enforcement events for Ge Healthcare It

InitiatedProduct (first record)TypeClassRecords
26 Aug 2013Merge Mammo is a multi-modality, vendor-neutral digital mammography workstation that enables imaging centers to use a siDeviceClass II1
11 Jun 2013The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by tDeviceClass II1
19 Apr 2013Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. DICOM devices DeviceClass II1
12 Mar 2013The Centricity Laboratory System is intended to be an information system designed to support the clinical and administraDeviceClass II1
12 Mar 2013The Centricity Laboratory System is intended to be an information system designed to support the clinical and administraDeviceClass II1
11 Mar 2013Centricity Perinatal and Centricity Intensive Care is intended to be used in clinical departments healthcare delivery syDeviceClass II1
18 Feb 2013Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18 Product Usage: is an image management sysDeviceClass II1
20 Nov 2012Centricity Laboratory Core Lab System 4.1 The Centricity Laboratory System is intended to be an information system desigDeviceClass II1
20 Nov 2012The Centricity Laboratory System is intended to be an information system designed to support the clinical and administraDeviceClass II1
20 Nov 2012The Centricity Laboratory System is intended to be an information system designed to support the clinical and administraDeviceClass III1

All 17 events for Ge Healthcare It

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "There is a potential loss of image(s) associated with the Centricity to Centricity (C2C) exam transfer module of Centricity PACS System versions 3.X and higher and 4.X and higher when transferring from the source to a destination server. When another process in the destination server attempts to access the same object or table, the transfer process of a particular image may be terminated. Once ter"

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: "Worldwide Distribution - US: Nationwide (AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN,…"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 10 Jun 2016. "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.