Revolution XR/d system control room PC model 5117866-2 with Software collector 5115434
FDA Recall Z-0002-2009 · Posted 2009-09-24
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Recalling FirmGE Medical Systems, LLC
Recall StatusTerminated
Product CodeKPR
Date Initiated2008-02-14
Date Terminated2012-01-07
Product Quantity129
Reason for Recall
GE Healthcare has recently become aware of a potential risk of observing a blank image after exposure on
Revolution XR/d systems equipped with HP 8200 PC user consoles that may impact patient safety.
It was reported that images acquired with off-center collimation for extremities with the
position selected as Digits to front or Digits to back are displayed as blank. Investigation into
th
Firm Action
Consignees were sent a GE Healthcare "Product Safety Notification" letter dated March 7, 2008. The letter was addressed to Hospital Administrators, Mangers of Radiology and Radiologists. The letter listed the Safety Issue, Affected Product, Safety Instructions, Corrective Action and Contact Information.
Root Cause
Software design
Distribution Pattern
Nationwide Distribution -- AL, AZ, CA, CO, FL, GA, HI, IL , IN, KY, LA, MD, MA, MI,MN,MS, MO, MT, NE, NH, NJ, NM, NY, NC, OH, OK OR, PA, SC, TN, TX, VA, WA, and WV.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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