Innova 2000, manufactured by GE Medical Systems, SCS

FDA device recall Z-2238-2010 · posted 2010-08-19 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

A hardware component (potentiometer and encoder)mismatch in Innova 2000 digital fluoroscopic imaging systems may cause a Source to Image Distance (SID) failure, which will cause the imager to fail to detect the distance between the imager and the patient. This will result in loss of the x-ray image if the recovery process is not performed. The error message to use the Emergency Back-Out Button for

Action taken

GE Healthcare sent a GE "Urgent Medical Device Correction" dated June 9, 2010letter to consignees. The letter was addressed to Hospital Administrators / Risk Mangers; Mangers of Radiology/Cardiology and Radiologists/Cardiologists. The letter described the Safety Issue, Affected Product Details; Safety Instruction; Product Correction and Contact Information. The letter detailed the method for identifying SID failure and the use of the emergency back-out buttoms to recover the X-ray image. A GE service representative will affix a label to the device on-site to remind operators how to recover from loss of X-ray from SID failure. Consignees may contact GE at 800 437-1171, option 4.

Root cause

Other

Status

Terminated

Product code

MQB

Quantity affected

885

Distribution

Worldwide distribution: States of AL, AZ, AR, CA, CO, CT,DE, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV,NH, NJ, NM, NH,NC, ND, OH, OK OR, PA, PR, RI, SC, SD, TN, TX, UT

Date initiated

2010-06-10

Date posted

2010-08-19

Date terminated

2014-04-01

Location

Waukesha, WI

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