GE Healthcare Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ, Innova 2121 IQ, Innova 3131 IQ , Innova 3100, Innova 4100.

FDA device recall Z-1318-2013 · posted 2013-05-14 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

While performing a fluoroscopic examination on the GE Innova systems, there is a potential of nonrecoverable loss of imaging modes with no advance warning, due to a relay failure in the power distribution box (PDB). Although no injuries have been reported due to this issue to date, there is risk of complications during the procedure as a result of imaging functionality loss.

Action taken

GE Healthcare did not send out customer letters. GE Healthcare completed the correction by replacing the faulty relay in all affected systems. As an effectiveness check, they have tracked all service requests for the field action to completion. These service requests recorded the repair of the affected units. Exceptions to completion of the service request were recorded as well. Records of field action completion will be retained per their processes and procedures. Should you have any questions or require additional information, please call (262) 548-2757.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

OWB

Quantity affected

713

Distribution

Worldwide Distribution -- Nationwide including the states of AL, AZ, AR, CA, CO, CT, DC, FL, GA, GUAM, HI, ID, IL , IN, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NH, NM, NY, NC, ND, OH,

Date initiated

2011-12-20

Date posted

2013-05-14

Date terminated

2014-03-13

Location

Waukesha, WI

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