Terumo Advanced Perfusion System 1; Integrated (Sarns) Centrifugal System Control Unit; Catalog number 801046.
- Recall Initiated
- October 16, 2006
- Posted
- February 14, 2007
- Terminated
- July 7, 2009
- Recall Number
- Z-0492-2007
- Quantity
- 343
- Firm Location
- Ann Arbor, MI
Reason for Recall
The pump may lose communication with the central control monitor, causing the monitor to display a service message "System Computer Needs Service" and to become non-operational.
Distribution
Worldwide distribution --- including USA and countries of 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 0102, 0106 through 0130, 0132 through 0155, 0157 through 0166, 0169 through 0216, 0218 through 0335 and 0338 through 0380.
Root Cause
Other
Action Taken
Consignees were notified of the problem via letter dated 11/10/06 and informed that they would be contacted to schedule a service call to install software upgrades. Installation of software upgrades began at customer locations on 10/16/06.