Terumo Advanced Perfusion System 1 Central Control Monitor; Catalog number 802100.
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-0337-2007
- 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 0047, 0049, 0052, 0054, 0055, 0065, 0066, 0069, 0071, 0072, 0074, 0076 through 0088, 0090 through 0111, 0113 through 0131, 0133 through 0276, 0278 through 0288, 0291 through 0293, 0295 through 0301 and 0303 through 0350.
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.