GE—Various Brivo and Optima Mobile Radiographic Systems: May Exhibit Technique Accuracy Problem
October 31, 2012 | Risk Management News
ECRI Institute’s complete weekly summary of medical device hazard and recall information is available in ECRI Institute’s Health Devices Alerts(HDA). For more information about HDA, contact us at firstname.lastname@example.org.
In an October 15, 2012, Important Electronic Product Radiation Warning letter submitted by ECRI Institute member hospitals, GE states that the systems below may exhibit a technique accuracy problem greater than the 10% specified in the product documentation. If the user rapidly increases or decreases the mAs or kV on the display, the technique displayed may be one Renard step or one kV increment off from the actual delivered exposure. This problem should only occur if the technique is adjusted >3 selections. If the user adjusts the techniques again after this rapid selection and before exposure, the display of the techniques and the actual delivered technique should be the same. Because of this problem, the above systems are not compliant with 21 Code of Federal Regulations (CFR) 1020.31 (a) "control and indication of technique factors—(4) accuracy" or the International Electrotechnical Commission (IEC) section 60601-2-54 clause 184.108.40.206.104.6. GE also states that this problem affects Optima XR200amx systems with digital upgrade only in its "degraded mode." The manufacturer has not confirmed the...