Terumo Advanced Perfusion System 1; Central Control Monitor; Catalog number 802100.
- Recall Initiated
- October 16, 2006
- Posted
- February 14, 2007
- Terminated
- July 7, 2009
- Recall Number
- Z-0436-2007
- Quantity
- 683
- Firm Location
- Ann Arbor, MI
Reason for Recall
Pump may stop without an audible tone as a result of quickly clearing the internal pump alarm condition or overpressure alert/alarm condition.
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 0036, 0045, 0047 through 0049, 0052, 0054, 0055, 0058, 0065 through 0067, 0069, 0071 through 0094, 0096 through 0254, 0256 through 0276, 0278 through 0301, 0303 through 0370, 0372 through 0376, 0378 through 0384, 0386 through 0686, 0688, 0690 through 0702, 0705 and 0706 through 0751.
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.