RecallDepth

Terumo Advanced Perfusion System 1; 6 inch diameter Roller Pump; Model 801041.

Company
Terumo Cardiovascular Systems Corp
Recall Initiated
October 16, 2006
Posted
February 14, 2007
Terminated
July 7, 2009
Recall Number
Z-0437-2007
Quantity
1,951 units
Firm Location
Ann Arbor, MI

Reason for Recall

The large roller pump may experience false "overspeed' error message when starting rotation, which will prevent the pump from operating; until the condition is cleared by power cycling the roller pump.

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 0030, 0033, 0034, 0036, 0037, 0038, 0041, 0042, 0043, 0045, 0046, 0047, 0048, 0049, 0052, 0054, 0055, 0057, 0058, 0061, 0063, 0064, 0069, 0072, 0075 through 0096, 0098 through 0119, 0122, 0124, 0125, 0127 through 0163, 0165, 0166, 0167, 0168, 0169, 0170, 0172, 0173, 0175, 0177, 0179, 0181, 0182 through 0231, 0233 through 0278, 0280 through 0481, 0483 through 0587, 0700 through 0753, 0757 through 0766, 0768, 0769, 0771 through 0787, 0789 through 0793, 0795 through 0898, 0900 through 0921, 0923 through 0978, 0980 through 1028, 1030 through 1051, 1053 through 1075, 1079 through 1268, 1270 through 1936, 1947 through 1951, 2000 through 2029, 2033, 2034, 2036 through 2038, 2042 through 2182 and 2186 through 2205.

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.

More recalls by Terumo Cardiovascular Systems Corp

View all recalls by this company →