GE Healthcare Recalls Innova IQ Systems Due to Missing Safety Label
GE Healthcare is recalling 48 Innova IQ systems manufactured between March 2010 and July 2011 because a safety label is missing from the gantry pivot section.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk of physical injury (collision) to staff members, which fits the 'High' severity criteria for risk-of-harm products where specific injury reports are not detailed in the truncated source text.
Plain-English summary
GE Healthcare, LLC is recalling 48 units of the Innova 2100IQ, Innova 3100IQ, and Innova 4100IQ Cardiovascular and Interventional Imaging Systems. The recall affects systems manufactured between March 2010 and July 2011. These systems were distributed worldwide, including in the United States and various international locations.
The recall is due to a missing safety label on the front cover of the Gantry Pivot section. The source text indicates that if a staff member stands in the region between the C-arm gantry pivot and the head section of the table, there is a risk of collision. The provided text is truncated and does not specify the exact nature of the injury or the number of reported incidents.
Healthcare facilities should identify affected units by checking the serial numbers listed in the recall notice. GE Healthcare is the recalling firm responsible for addressing the defect.
The recalled product
- Product
- GE Healthcare, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ, Cardiovascular and Interventional Imaging System.
- Manufacturer
- GE Healthcare, LLC
- Hazard
- Affected units
- 48
Distribution
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