Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required); Model 801763.
FDA Recall Z-0306-2007 · Posted 2006-12-27
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Recalling FirmTerumo Cardiovascular Systems Corp
Recall StatusTerminated
Product CodeDTQ
Date Initiated2006-11-10
Date Terminated2008-06-19
Product Quantity488
Reason for Recall
Improperly adjusting the occlusion setting may result in a pump jam error and pump stoppage.
Firm Action
A letter dated 11/10/06 was sent to consignees providing them with an addendum (814576R/B) to the operators'' manual. Users of systems produced prior to May 2006 received only this addendum, but users produced between May and November 2006 had previously received addendum 814576R/A which is corrected and to be replaced by the new addendum 814576R/B.
Root Cause
Other
Distribution Pattern
Worldwide, including USA, 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.
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.
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