FDA · Medical device recall

GE Healthcare innova 3100… and 2 more products

Oct. 31, 2012 Class II

Date: Oct. 31, 2012
Risk class: Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
Status: Terminated
Filed by: GE Healthcare, LLC
Reason: It was discovered of a potential failure of the spectral filter mechanism inside the collimator of the innova 3100, innova 3100-IQ and innova 3131-IQ systems.
Distribution pattern: Nationwide distribution

3 products in this recall

GE Healthcare innova 3100…

Product: GE Healthcare innova 3100, Mobile X-ray system. The innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally , rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures.
Quantity: 199 installed in the US
Codes and lots: Model number 5892935G052G
Recall started: Dec. 20, 2011
Device type: System, X-Ray, Angiographic
Root cause (FDA): Radiation Control for Health and Safety Act
What the company told customers: GE Healthcare will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services. A GE Healthcare Service Representative will replace the collimator to address the issue. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. Further questions please call 262-513-4122.
Recall number: Z-0113-2013

GE Healthcare innova 3100-IQ…

Product: GE Healthcare innova 3100-IQ, Mobile X-ray system The innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally , rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures.
Quantity: 199 installed in the US
Codes and lots: Model number - 5892935G052G
Recall started: Dec. 20, 2011
Device type: System, X-Ray, Angiographic
Root cause (FDA): Radiation Control for Health and Safety Act
What the company told customers: GE Healthcare will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services. A GE Healthcare Service Representative will replace the collimator to address the issue. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. Further questions please call 262-513-4122.
Recall number: Z-0114-2013

GE Healthcare innova 3131-IQ Mobile X-ray system…

Product: GE Healthcare innova 3131-IQ Mobile X-ray system. The innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally , rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures.
Quantity: 199 installed in the US
Codes and lots: Model number - 5892935G052G
Recall started: Dec. 20, 2011
Device type: System, X-Ray, Angiographic
Root cause (FDA): Radiation Control for Health and Safety Act
What the company told customers: GE Healthcare will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services. A GE Healthcare Service Representative will replace the collimator to address the issue. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. Further questions please call 262-513-4122.
Recall number: Z-0115-2013

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-0113-2013, Z-0114-2013, Z-0115-2013. The agency record governs; check it and the company before acting.

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