U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
fluoroscopic imaging system - Product Code MQB
원인
Incorrect dose data: ge healthcare has found that after 6 days and 4 hours without performing a system reset or a system reboot (turning it off/on), the displayed dose data on these systems (innova 3100 / innova 4100 with bolus option) may be underestimated by up to 50%. in order to avoid this issue, it is necessary to perform a system reset or reboot every day. ge healthcare is working on a c.
조치
GE sent all customers with affected units a letter on 11/15/07 titled Urgent Medical Device Correction. In the US this was sent by a traceable means (either US Postal Service with receipt acknowledgement (registered mail) or equivalent courier service such as FEDEX overnight Delivery). The letter was sent to 3 titles within the affected accounts; Hospital Administrator, Manager of Radiology/Cardiology and Radiologist/ Cardiologist. A correction letter identified a short term recommendation to perform a system reset or reboot every day and stated that a software correction will be installed at their site at no cost.