220/240V AC, Advanced Perfusion System 1 Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use in e

FDA device recall Z-1978-2013 · posted 2013-08-15 · Terminated

Recall details

Recalling firm

Terumo Cardiovascular Systems Corporation

Reason for recall

TCVS is taking action to update the Operators Manual with the specific instructions to respond to this condition and will issue a labeling addendum for current users. In the event of a false high pressure alarm condition occurs that displays a "999" pressure reading and results in stopping a pump, this pressure display can be cleared and the pump re-started by disconnecting the pressure transducer from the system.

Action taken

Terumo sent an Urgent Medical Device Recall notification letter dated July 26, 2013 to all affected customers. The letter identified the affected product, reason for correction, potential hazards of the recall issue, the correction to be implemented, and customer instructions for replying to the recall notification. Terumo CVS is providing an addendum to be placed in the Operator's Manual at the beginning of Chapter 7, Modules. Questions or concerns are directed to Terumo CVS Customer Service at 1-800-521-2818, Recall Fax 1-877-275-6860. Customer Service hours are Monday to Friday 8am-6pm ET.

Root cause

Software design

Status

Terminated

Product code

DTQ

Quantity affected

1657

Distribution

Worldwide Distribution - US Nationwide in the states of :AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MSMT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, S

Date initiated

2013-07-26

Date posted

2013-08-15

Date terminated

2017-02-07

Location

Ann Arbor, MI

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