Terumo Advanced Perfusion System 1 Control Unit; Catalog number 801046.
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-0335-2007
- 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 0020 through 0025, 0030 through 0036, 0038 through 0040, 0042, 0044, 0045, 0047 through 0081, 0083, 0084, 0086 through 0102, 0106 through 0110, 0112 through 0130, 0132 through 0137, 0139 through 0147, 0149 through 0154, 0157 through 0166, 0169 through 0175 and 0177 through 0189.
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.