Emission Computed Tomography System. Including Model numbers: 2200967, ASM001080, ASM001083, ASM001092, ASM001099, ASM000085, 10036800109, and Varicam.
This recall has been terminated (originally issued October 7, 2004).
- Company
- General Electric Med Systems Llc
- Recall Initiated
- September 3, 2004
- Posted
- October 7, 2004
- Terminated
- July 24, 2006
- Recall Number
- Z-0012-05
- Quantity
- 853 units
- Firm Location
- Waukesha, WI
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide throughout the United States and worldwide.
Lot / Code Info
Each unit has a unique serial code. All serial numbers are being recalled.
Root Cause
Other
Action Taken
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.