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.
Product monitoring has determined that the connection bracket shows potential mechanical play at the or table interface for some procedures. this is due to the hole in the lock washer, which is responsible for locking the accessory to the or table, being too large.
조치
Urgent Device Correction Letters were sent by Federal Express to affected US hospitals on October 22, 2009. The letter stated the technical description, potential hazard, and the recommended precaution. The letter asked customers to immediately verify whether their Connection Bracket is affected thru the FaxBack provided. Questions or need for additional information can be directed to customers' local MAQUET representative.
Nationwide Distribution -- USA, including states of SC and PA.
제품 설명
Maquet Accessories, Connection Bracket. Catalogue # 1180.36A0. || An accessory component for the MAGNUS operating table system. Used to mount head positioning accessories.