Z-0012-05

Emission Computed Tomography System. Including Model numbers: 2200967, ASM001080, ASM001083, ASM001092...

Name: Z-0012-05 Emission Computed Tomography System. Including Model numbers: 2200967, ASM001080, ASM001083, ASM001092...
Creator: General Electric Med Systems LLC
Published: 2004-09-03
License: https://open.fda.gov/license/

GE Healthcare / initiated 2004-09-03 / Terminated

FDA source

General Electric Med Systems LLC began a recall of Emission Computed Tomography System. Including Model numbers: 2200967, ASM001080, ASM001083, ASM001092, ASM001099, ASM000085, 10036800109, and Varicam on 2004-09-03. The reason FDA records is "GE Healthcare received reports of intermittent low ejection fraction (EF) results for MUGA (multi-gated acquisitions) studies on Millennium VG systems. This issue can occasionally lead to distortions in the volume curve...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0012-05
Status: Terminated
Initiated: 2004-09-03
Posted: 2004-10-07
Terminated: 2006-07-24
Recalling firm: GE Healthcare
Product: Emission Computed Tomography System. Including Model numbers: 2200967, ASM001080, ASM001083, ASM001092, ASM001099, ASM000085, 10036800109, and Varicam.
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: GE Healthcare received reports of intermittent low ejection fraction (EF) results for MUGA (multi-gated acquisitions) studies on Millennium VG systems. This issue can occasionally lead to distortions in the volume curve in some MUGA studies, and result in calculated EF values lower (never higher) than actual values. A low EF value could lead to a physician decision to stop needed treatment.
FDA root cause: Other
Action: A letter dated August 5, 2004 was released to customers describing the issue and recommending that users pay special attention to any volume curve which appears to be abnormal or any EF values that appear to be lower than expected, and not to rely soley on this value for diagnosis purposes until they recieve the SW patch. A SW patch will be distributed shortly to all affected systems.
Quantity in commerce: 853 units
Distribution: Nationwide throughout the United States and worldwide.
Product codes and lots: Each unit has a unique serial code. All serial numbers are being recalled.

Product code KPS

K953801Class IIVaricamElscint, Inc. / cleared 1995-11-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)