Terumo Advanced Perfusion System 1, Catalog number 801764, 220/240V System 1 base, Terumo Cardiovascular System, Ann Arb

FDA device recall Z-2481-2010 · posted 2010-09-23 · Terminated

Recall details

Recalling firm

Terumo Cardiovascular Systems Corporation

Reason for recall

The design document states that the oxygen sensor would operate for 300,000 hours but the supplier of the oxygen sensor indicated that it has a 100,000 hour warranty. The oxygen sensor is a consumable part that slowly depletes over time. At the end of its service life, a depleted oxygen sensor results in a gas system calibration failure or a message to the user prompting service for the gas syst

Action taken

Terumo issued a URGENT MEDICAL DEVICE CORRECTION letter dated September 10, 2010, identifying the affected product, the issue prompting the correction, and what actions are to be taken by the customer. The firm included the addendum to the operators manual with the recall letter. The addendum recommended replacement of the oxygen sensor every six months instead of every 12 months. The addendum provided additional user instructions in the event of a calibration failure of the sensor. Customers are to complete and return the enclosed Customer Response Form to the firm. Terumo CVS Customer Service can be contacted by 1-800-521-2818 Monday through Friday, 8 AM 6 PM EST.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

DTQ

Quantity affected

1315

Distribution

Worldwide Distribution: USA, including the states of AL,AZ, CA, CO, CT, DC, FL, GA, HI, IA, IN, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WI,

Date initiated

2010-09-10

Date posted

2010-09-23

Date terminated

2011-12-20

Location

Ann Arbor, MI

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