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
Accelerator, linear, medical - Product Code IYE
원인
Incorrect drug dosage due to "age limit" and patient weight data item issue.
조치
The firm, Elekta, sent an "URGENT IMPORTANT FIELD SAFETY NOTICE 371-01-MSQ-005" to all customers on 12/9/2015. The notice informs users of the specific product and version numbers affected by both issues, also includes a workaround for both issues. A copy of the Important Field Safety Notice is to be kept with the most current labeling and all personnel working with the product should be made aware of the content of the letter. The customers are instructed to return the acknowledgement form to their local Elekta as soon as possible-Fax: 408-830-8003.
If you have any queries about this Notice, please contact your local Elekta office, call 408-830-8000 or toll free: 855-693-5358 or www.elekta.com.
Worldwide Distribution: US (nationwide) including states of: AK, AZ, AR, CA, CO, CT, DE DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, ,MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, and WY; and countries of: Antiqua & Barbuda, Australia, Austria, Bahama, Bahrain, Canada, Czech Republic, Germany, Hungary, Saudi Arabia, Sweden, Turkey, & United Kingdom.
제품 설명
MOSAIQ Oncology Information System || MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.