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 917

FDA device recall Z-3084-2011 · posted 2011-08-29 · Terminated

Recall details

Recalling firm

Maquet Inc.

Reason for recall

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

DTQ

Quantity affected

299 units

Distribution

Nationwide Distribution

Date initiated

2011-06-20

Date posted

2011-08-29

Date terminated

2012-10-16

Location

Wayne, NJ

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