Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763.
Brand
Terumo Cardiovascular Systems Corp
Lot Codes / Batch Numbers
Serial numbers 0013, 0017, 0019 through 0039, 0041 through 0163, 0165 through 0200 and 0203 through 0244.
Products Sold
Serial numbers 0013, 0017, 0019 through 0039, 0041 through 0163, 0165 through 0200 and 0203 through 0244.
Terumo Cardiovascular Systems Corp is recalling Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source r due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026