GE Healthcare innova 3100, Mobile X-ray system. The innova systems are indicated for use in generating fluoroscopic imag

FDA device recall Z-0113-2013 · posted 2012-10-17 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

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.

Action taken

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.

Root cause

Radiation Control for Health and Safety Act

Status

Terminated

Product code

IZI

Quantity affected

199 installed in the US

Distribution

Nationwide distribution

Date initiated

2011-12-20

Date posted

2012-10-17

Date terminated

2013-09-18

Location

Waukesha, WI