Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763.
This recall has been terminated (originally issued December 30, 2006).
- Recall Initiated
- October 12, 2004
- Posted
- December 30, 2006
- Terminated
- February 1, 2007
- Recall Number
- Z-0322-2007
- Quantity
- 4,740 for all affected products
- Firm Location
- Ann Arbor, MI
- Official Source
- View on FDA website ↗
Reason for Recall
Device module(s) may fail to properly initialize during start up, thus resulting in that single module being inoperable and a red 'X' being displayed on the monitor screen.
Distribution
Worldwide Distribution-USA and countries Australia, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand and United Arab Emirates.
Lot / Code Info
Serial numbers 0013, 0017, 0019 through 0039, 0041 through 0163, 0165 through 0200 and 0203 through 0244.
Root Cause
Other
Action Taken
U.S. consignees were sent an addendum to the operators manual on October 12, 2004 instructing them to cycle power to the unit to clear the error. International distributors were requested to provide this information to their customers on 12/15/04, but Terumo has not yet received confirmation that this was completed.