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.
Maquet hl 20 twin pump modules may unintentionally increase speeds for a 1.5-2 second period of time before returning to its original speed.
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Maquet sent a PRODUCT RECALL NOTIFICATION LETTER/return response forms, dated June 17, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the affected product until a software update was performed by their trained technicians. Customers were also asked to forward the information contained in the notification letter to all users and to all appropriate Biomedical Staff.
Customers were instructed to acknowledge receipt of the notification letter by completing and faxing back the attached response form to 973-807-9210 whether or not they have any of the affected product.
For questions customers were instructed to contact their local MAQUET representative.
For questions regarding this recall call 973-709-7994.
Maquet HL Console for Heart Lung Machine HL20 || HL 20 4-pumps console base: P/N 917741 || HL 20 5-pumps console base: P/N 917751 || Intended for use as an extracorporeal circulation device for perfusion lasting not more than six hours. The HL console is equipped with a rack for accommodating the system's electronic modules.