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
Image-intensified fluoroscopic x-ray system - Product Code JAA
원인
Inaccurate cassette size display reading/ inaccurate mas reading: 1. when the device is in pbl mode and a larger film cassette is inserted into the table bucky (replacing a smaller cassette) after a protocol is selected on the console, the collimator will not adjust to the larger cassette size. the collimator stays at the original smaller cassette size and allows the operator to take an exposure.
조치
Consignees were notified by two "Product Safety Notification" letters on July 10, 2007. Each letter addressed one of the two safety issues with the affected product. The letters provided safety instructions on how avoid the software error and informed users that their representative would contact them to schedule a visit for a software correction installation.
Worldwide Distribution --USA including states of: AK, AL, AR, CA, CO, CT, FL, GA, IA, ID, IL ,IN, LA, MA, MD, MI, MO,MS, NC, ND, NE, NH, NJ, NM, NV, OH,OK, OR, PA, SC, SD, TN, TX, UT, VA, VT and WA; USA territory of: PR and countries: EGYPT, SAUDI ARABIA, MACEDONIA, FRANCE and GREAT BRITAIN.
제품 설명
Precision 500D Classical R&F; System with control room PC; Image-intensified fluoroscopic x-ray system; ; Model Number: 5117866-27.