GE Healthcare, Innova 3100 and Innova 4100 systems. The Digital Fluoroscopic Imaging System is indicated for use in diag

FDA device recall Z-1616-2013 · posted 2013-06-28 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

GE Healthcare reported a potential safety issue due to temporary loss of X-Ray Imaging Modes during Collimator Auto-Calibration which affects Innova 3100 and Innova 4100 Systems.

Action taken

A Customer Letter was not originally sent. GE Healthcare has retrospectively re-assessed the reportability of the field action and has determined that the action should be reported to the FDA. GE Healthcare has already updated all of the affected Innova 3100 and Innova 4100 systems that were distributed. As an effectiveness check, they have tracked all service requests for the field action to completion. These service requests have recorded the repair of the affected units. Exceptions to completion of the service request have been recorded as well. Records of field action completion have been retained per their processes and procedures. If you have any questions, please call 262-548-2757. For questions regarding this recall call 262-513-4122.

Root cause

Software design

Status

Terminated

Product code

OWB

Quantity affected

48

Distribution

Worldwide distribution - USA including AZ, CA, CO, FL, ID, IL, ME, NV,NY, NC, OK, TN, UT, and WI; and Internationally to Canada, Chile, France, Germany, Italy, Japan, Korea, Norway and Spain.

Date initiated

2011-05-16

Date posted

2013-06-28

Date terminated

2014-03-13

Location

Waukesha, WI

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