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
Surgical Lamp - Product Code FTD
원인
Several reports have been received regarding one model of spring arm (acrobat 200 series) in combination with surgical light from various manufacturers. all incidents pertain to a crack on the front joint of the acrobat arm.
조치
Urgent Device Correction letters, dated October 7, 2009, were sent out by FedEx. The letter identified the affected products and asked customers to call 1-888-627-8383 #1, if they have any questions. The letter also provided a Technical Description along with a Customer Fax Response form. The letter stated the potential hazard and recommended precaution. If customers need additional info or have any questions they should contact their local MAQUET representative.
HANAULUX 2004-2005 TV Spring Arm, P/N: 569002998. || Intended to provide visible illumination for the surgical field or for the examination of the patient.