Terumo Advanced Perfusion System 1 Pressure Monitoring; Catalog number 802112.

FDA device recall Z-0331-2007 · posted 2006-12-30 · Terminated

Recall details

Recalling firm

Terumo Cardiovascular Systems Corp

Reason for recall

Device module(s) may fail to properly initialize during start up, thus resulting in that single module being inoperable and a red 'X' being displayed on the monitor screen.

Action taken

U.S. consignees were sent an addendum to the operators manual on October 12, 2004 instructing them to cycle power to the unit to clear the error. International distributors were requested to provide this information to their customers on 12/15/04, but Terumo has not yet received confirmation that this was completed.

Root cause

Other

Status

Terminated

Product code

DTQ

Quantity affected

4,740 for all affected products

Distribution

Worldwide Distribution-USA and countries Australia, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South

Date initiated

2004-10-12

Date posted

2006-12-30

Date terminated

2007-02-01

Location

Ann Arbor, MI

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