All recalls8,424 total
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware updates have been implemented through Abiomed s servicing process; therefore, AICs that have not received service are pending these updates. Issue 1: The proximity of the internal Video Graphics Array cable to the Digital Signal Processor chipset on the Impellatronic printed circuit assembly could potentially result in Electrostatic Discharge coupling into the Digital Signal Processor which may interrupt motor controls. Issue 2: There is a potential for the Compact Flash Memory Card dislodgement due to external applied forces, which could result in AIC startup failures and data logging issues. Issue 3: Improper routing of the fan wire within the AIC could lead to fan wire damage, which may result in console boot-up failure. Issue 4: Potential capacitor related issues on the Power Battery Manager, including the potential for the capacitors to cause pump stop, purge stop, and/or single fan fuse failures.
Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window
Lack of Assurance of Sterility
Contains undeclared FD&C Yellow 6
Foreign Material (plastic)
Labeling: Missing Label
It was reported that plates 2 and 3 were marked as passed , although it appeared that QC had not been performed on these plates, despite samples being measured. The potential clinical hazards include false or missed detection of M-protein (false positive); and falsely elevated or decreased M-protein concentration.
Undeclared Yellow #5
Undeclared Milk, Soy, Red #40.
Undeclared Milk, Red #40.
Undeclared Soy (with mitigating circumstances)
Undeclared Milk, Wheat, Soy, Yellow #5, Green #3.
Undeclared Milk, Walnuts, Eggs, Wheat, Soy.
Undeclared Red #40, Blue #1, Blue #2
Undeclared Milk, Eggs, Yellow #5.
Undeclared Milk, Red #3, Red #40, Blue #1, Blue #2.
Undeclared Red #40
Undeclared Milk, Almonds, Soy, Sulfites.
Undeclared Milk.
Undeclared Milk, Peanuts.
Undeclared Milk, Yellow #5.
Undeclared Milk, Pistachios, Yellow #5, Blue #1.
Undeclared Soy (with mitigating circumstances), Yellow #5, Blue #1
Undeclared Milk, Pecans.
Undeclared Milk, Eggs, Yellow #5.
Undeclared Milk, Walnuts, Eggs.
Undeclared Milk, Soy.
Undeclared Milk, Yellow #5.
Undeclared Milk, Yellow #6.
Undeclared Milk, Soy, Sulfites.
Undeclared Milk, Red #40.
Undeclared Milk, Almonds, Soy.
Undeclared Milk, Almonds, Soy.
Undeclared Milk, Cashews, Soy, Sulfites.
Undeclared Milk, Soy, Yellow #5, Red #40, Green #3.
Undeclared Milk, Almonds.
Undeclared Milk, Yellow #5.
Undeclared Milk, Red #40, Blue #1.
Undeclared Milk, Walnuts, Sulfites.
Undeclared Milk, Red #40, Blue #1.
Undeclared Milk, Soy.
Undeclared Milk, Soy, Yellow #5, Blue #1.
Undeclared Milk, Red #40.
Undeclared Milk, Walnuts.
Undeclared Milk, Wheat, Soy.