Terumo Advanced Perfusion System 1 Electronic Oxygen Blender/analyzer; Catalog number 801188.
FDA Recall Z-0294-2007 · Posted 2006-12-19
Recalling FirmTerumo Cardiovascular Systems Corp
Recall StatusTerminated
Product CodeDTQ
Date Initiated2004-01-01
Date Terminated2007-02-02
Product Quantity199 units
Reason for Recall
The flow meter could malfunction resulting in loss of touchscreen control of the gas system, but the alternate mechanical control will remain operable.
Firm Action
U.S. consignees were visited by firm representatives between January 2004 and September 2005 and the device modified to correct the problem. Approximately 32 exported units are still in need of being upgraded.
Root Cause
Other
Distribution Pattern
Worldwide, including USA, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Singapore, South Africa, South Korea, Thailand and United Arab Emirates.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.