FDA Device Recall Z-0012-05: General Electric Med Systems LLC

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0012-05.

Recall Res Number

Z-0012-05

Recalling Firm / Manufacturer

General Electric Med Systems LLC

FEI Number

2126677

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2004-09-03

Date Posted

2004-10-07

Date Terminated

2006-07-24

Product Code

KPS

Event Number

29988

Product Quantity

853 units

Product Description Emission Computed Tomography System. Including Model numbers: 2200967, ASM001080, ASM001083, ASM001092, ASM001099, ASM000085, 10036800109, and Varicam.

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.

Action Details 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.

Distribution Pattern Nationwide throughout the United States and worldwide.

Code Information / Serial Numbers Each unit has a unique serial code. All serial numbers are being recalled.

Related Establishments / Registrations

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Medical Device Recall: Z-0012-05

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer