GE Healthcare Innova 4100 Digital Fluoroscopic Imaging (Cardiovascular Imaging System
FDA Recall Z-1522-2008 · Posted 2008-09-30
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Recalling FirmDatex - Ohmeda, Inc
Recall StatusTerminated
Product CodeMQB
Date Initiated2008-05-19
Date Terminated2016-06-30
Product Quantity87
Reason for Recall
GE Healthcare has become aware of a potential condition that may impact operator or patient safety. One customer has reported that inability to terminate X-ray exposure after releasing the hand switch control (located in the control room).
Firm Action
An Urgent Medical Device Correction letter, dated June 2008 was sent to customers The letter described the issue, affected products and provided short term user recommendations. GE developed a new software release that corrects this condition and will launch the corrective action to upgrade all affected systems.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution - AL, AZ, CA, FL,, GA, HI, IA,IL, IN, KY, LA,MA, MD, MI, MO, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WI, and WV, Puerto Rico. OUS to include: Australia, Byelarus, China, Denmark, France, Germany, Greece, Honduras, Iran, Iraq, Italy, Japan, Latvia, Lebanon, Mexico, Poland, Russia, Saudi Arabia, Turkey, United Kingdom, and Venezuela.
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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