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
ALM SURGICAL LAMPS - Product Code FTD
원인
The screws holding the prismatic triple surgical lights may break due to dynamic multidirectional bending stress. the firm has received one complaint report.
조치
An "Urgent Device Correction" letter dated February 23, 2009 was mailed by FedEx Tracking to all affected consignees. The letter described the issue, potential hazard and recommended precaution. Customers were instructed to complete the enclosed "Customer Response Fax Form" and return it via fax (1-732-667-1903) to Maquet, Inc. Maquet, Inc. will schedule repair service of the affected units once the "Customer Response Fax Form" is received. Direct questions to your local Maquet, Inc. Representative.
Alm Prismatic Surgical Light 5004 SF; || Maquet SA. || ALM PRISMATIC (PRC) Surgical Lights are used to provide visible illumination for the surgical field or for the examination of the patient. PRC is designed to eliminate shadow, reduce reflected heat, and illuminate surgical incisions of all depths during surgical procedures.