Innova 2000 The principle system components include a C-arm, image acquisition, processing and archiving capabilities. T

FDA device recall Z-0393-2011 · posted 2010-11-16 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

GE Healthcare has become aware of a potential video splitter failure with certain Innova 2000 and 4100 X-ray systems that may impact patient safety. A potential video splitter failure inside the GE equipment cabinet could occur with no advance warning and thereby prevent x-ray image display. Should this occur, the system cannot be recovered without service intervention. GE Healthcare has obse

Action taken

GE Healthcare sent an " Urgent Medical Device Correction" letter dated July 9, 2009, to Hospital Administrators / Risk mangers, Managers of Radiology / Cardiology and Radiologists / Cardiologists. The letter identified the product, described the Safety Issue, Affected Product Details, Safety Instructions Product correction and Contact Information. Hospitals were instructed to establish emergency workflow procedures should a component stop operating during a patient examination. A GE Healthcare service representative would contact each customer and correct all affected systems. For questions regarding this recall call (262) 548-2731.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

MQB

Quantity affected

365

Distribution

Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, DC, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX UT, VA, WA, WV

Date initiated

2009-08-06

Date posted

2010-11-16

Date terminated

2012-05-17

Location

Waukesha, WI

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