Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States).
- Recall Initiated
- November 1, 2005
- Posted
- June 30, 2007
- Terminated
- June 23, 2009
- Recall Number
- Z-0599-2007
- Quantity
- 485 of both model numbers
- Firm Location
- Ann Arbor, MI
Reason for Recall
The power manager subsystem may not initialize properly during start-up, which will cause the battery status monitoring and battery switching operations to not be fully functional.
Distribution
Worldwide distribution ---- Nationwide and countries of Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Philippines, Republic of Georgia, Russia and Saudi Arabia.
Lot / Code Info
Serial numbers 0006 through 0066 and 0100 through 0171 may be affected. Serial numbers 0031, 0060, 0105, 0106, 0138, 0142 and 0149 have been corrected and the other serial numbers listed will be corrected.
Root Cause
Other
Action Taken
Firm repaired the affected units beginning in November 2005, upon receipt of complaints of failure. The firm issued a Device Correction Letter dated 6/6/07 notifying all users of the problem and advising them that they will be visited and their units upgraded as replacement components become available.