Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required); Models 801763.
This recall has been terminated (originally issued December 27, 2006).
- Recall Initiated
- May 1, 2004
- Posted
- December 27, 2006
- Terminated
- July 14, 2009
- Recall Number
- Z-0314-2007
- Quantity
- 12
- Firm Location
- Ann Arbor, MI
- Official Source
- View on FDA website ↗
Reason for Recall
The gas system may fail calibration prior to use due to incorrect gas system flowmeter software.
Distribution
Worldwide distribution, including USA, Belgium, Germany, Japan, Korea and Republic of China.
Lot / Code Info
Serial numbers 0093 and 0104 through 0114.
Root Cause
Process control
Action Taken
U.S. consignees were visited and corrections made between May 2004 and November 2005. Foreign affiliates were instructed to make corrections on international units, but the firm has not received confirmation yet that these units have been corrected.
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