GE Healthcare, PET VCAR
Medical device recall Z-1551-2013. Published in FDA’s Enforcement Report on Jun 26, 2013.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jun 26, 2013. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 13 states named in where it went
- 231 (38 US; 193 OUS) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
GE Healthcare has recently become aware of a potential safety issue with respect to the automated PERCIST response criteria calculation applied in the PET VCAR application on Advantage Workstation or AW Server.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare, PET VCAR. PET VCAR application software is affected if installed on any of the following versions of the Advantage Workstation and AW Server: Advantage Workstation 4.6, Volume Share 5 enhanced vxtl.11.3, vxtl.11.3 ext1, or vxtl.11.3 ext2 AW Server 2.0, Volume Share 5 enhanced vxtl.11.3, vxtl.11.3 ext1, or vxtl.11.3 ext2 PET VCAR (Volume Computer Assisted Reading) is a PET/CT software package which can be used by the clinician to assist in diagnosis, staging, treatment planning and monitoring treatment response.
231 (38 US; 193 OUS), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Mfg Lot or Serial # 00000L3A331FA4 00000L3A3318C4 0S804VCUPETAWS 00S804VCUPETAW 00000LE23E908A 00000LA707B8CD 0000S704783AWS 00000L3AB67847 000D1L3AB67847 00000LA70D61FE 0000G297117701 00000LFB44C088 00000LA70D6257 00000L2E5D97AC…
Every code shown here, 2,000 characters
Mfg Lot or Serial # 00000L3A331FA4 00000L3A3318C4 0S804VCUPETAWS 00S804VCUPETAW 00000LE23E908A 00000LA707B8CD 0000S704783AWS 00000L3AB67847 000D1L3AB67847 00000LA70D61FE 0000G297117701 00000LFB44C088 00000LA70D6257 00000L2E5D97AC 00000LA704C3E7 00000L021DFE17 00000L97BF02A6 00000L3AA73A5B 00000LA70AB28E 00000L3AB4D639 00000L3AB501ED 00000L3AA80D28 00000L3AB4D6CC 00000L3AB50126 SNYPHAWSERVER2 00000X12335005 00000LAEDF9764 000S704783HDCT 0D1S704783HDCT SSENTARAPETDST 00000LB8CDB088 00000LA70CF2BD 00S681342AWONC 00000L97BD2680 0S856247PETUPS 00000L3AAD0E3F 00000L3A6AB2B5 00000L3A3D0C38 00000LA7053E64 00000LA7053E11 00000H12361003 00000H12361004 0000AD13018005 00000E12291003 00000E12291004 0000AV12212003 0000AV12212004 0000AV12213001 0000AV12213002 00000R12268002 00000R12268003 00000N12226004 00000N12226005 00000L3A330899 00000L3A87FE86 00000L3A86843C 00000L3A3305A1 00000LA713783D 00000LA712A01B 00000LA7142C7C SCT428868CN4AW 00000L3AA6F64A 00000X12335002 00000Q12328002 00000Q12328001 00000H12361005 0000AP12152002 0000AP12152001 00000L02135882 00000L0257B5A9 00000L026873C9 00000L3AB68D6E 00000L12130007 00000LA7053E56 000D1LA7053E56 00000L3AADF306 00000Q13066002 00000Y13070003 00000L026F4B0A 00000R12268005 00000L3A8FD336 00000L12130001 00000L12130002 00000L02167931 00000LA707FDCA 00000LA707FDC7 00000L02687367 00000L3A373C91 00000L020E0B5F 00000LA8CE7F5A 00000L02687172 00000L3AB1FAF2 00000L021500C2 00000Y13070001 0000AE12073008 00000H12275003 00000N12226001 00000L12130003 00000L12130004 00000L12130005 00000L12130006 00000P12319006 00000P12319004 0000AG12311002 00000L12130010 00000X12335004 00000P12319007 00000X12335003 00000Q12328003 0000AE12073003 0000AV12227003 00000H12361002 00000G12164003 00000L024087F6 00000E12291002 0000AD13018004 00000U12145004 00000U12145001 0000AP12152003 0000AP12152004 00000R12268001 00000H12275001 00000J12283001 0000AE12073005 0000AD13018002 00000LA70D6AAB 00000L2E5C60F0 00000A12147003 00000A12147004 00000X12335001 00000LE23E92C2 00000L3A55F90A…
FDA’s list runs to 3,484 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution - USA including CA, CO, CT, FL, GA, IL, NY, NY NC OH, TX, VA, WV, WI. Internationally to: AUSTRALIA, AUSTRIA, BAHARIN, CANADA, CHILE, CHINE, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GEORGIA, GERMANY, HONG KONG, INDIA, INDONESIA, ITALY, JAPAN, KOREA, MEXICO, MOROCCO, NIGERIA, POLAND, ROMANIA, RUSSIA,SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED KINGDOM.
The states and territories these words name
13 states and territories.
Every one of them
- California
- Colorado
- Connecticut
- Florida
- Georgia
- Illinois
- North Carolina
- New York
- Ohio
- Texas
- Virginia
- Wisconsin
- West Virginia
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on May 9, 2013.
- FDA classified it on Jun 18, 2013.
- FDA’s Enforcement Report published it on Jun 26, 2013.
- FDA terminated it on Jan 21, 2014.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Healthcare, LLC, of Waukesha, WI.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 3,484 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.