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).
This recall has been terminated (originally issued December 29, 2008).
- Recall Initiated
- April 17, 2008
- Posted
- December 29, 2008
- Terminated
- July 7, 2009
- Recall Number
- Z-0446-2009
- Quantity
- 161
- Firm Location
- Ann Arbor, MI
- Official Source
- View on FDA website ↗
Reason for Recall
The power supply may fail to charge the batteries due to various hardware malfunctions.
Distribution
Worldwide distribution: USA, Australia, Belgium, Canada, Colombia, Dominican Republic, Honduras, Hong Kong, Indonesia, Japan, Jordan, Kuwait, Malaysia, Mexico, Philippines, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, United Arab Emirates, and Viet Nam.
Lot / Code Info
Serial numbers 0188 through 1027.
Root Cause
Nonconforming Material/Component
Action Taken
Terumo notified U.S. consignees via Urgent Medical Device Correction: Safety Advisory recall letter dated 4/17/08 and international consignees were notified via email on 4/24/08 informing them of the potential problem.