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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 61763

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 21, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Terumo Cardiovascular Systems Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

Terumo Advanced Perfusion System 1 System 1 Base, 100/120V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

Z-2009-2012
Recall number
Z-2009-2012
Initiated
June 21, 2012
Classification
Class II
Status
Terminated
Quantity
992 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Terumo Cardiovascular Systems has received reports of several issues that manifest themselves as communications or power failures in the system network for Terumo Advanced Perfusion System 1. Issues that affect a single pump or module are: " The appearance of a red X on a single pump or module icon on the CCM " The appearance or a single '?' symbol on a pump or module icon on the CCM " The fai

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Terumo Cardiovascular Systems has received reports of several issues that manifest themselves as communications or power failures in the system network for Terumo Advanced Perfusion System 1. Issues that affect a single pump or module are: " The appearance of a red X on a single pump or module icon on the CCM " The appearance or a single '?' symbol on a pump or module icon on the CCM " The fai

Code information

Catalog number: 801763 and serial number: 0011-0335,0337-0610, 1001-1034, 1037-1049,1100, 1103-1106, 1109-1445,and 1447-1450.

Distribution pattern

Worldwide Distribution-USA (nationwide) including the states of , AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV and the countries of ARGENTINA, AUSTRALIA, BELGIUM, CANADA, CHILE, COLOMBIA, Costa Rica, Dominican Republic, Egypt, Germany, Guatemala, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, UNITED ARAB EMIRATES (UAE), and Vietnam.

device · product 2 of 2

Terumo Advanced Perfusion System 1 System 1 Base, 220/240V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

Z-2010-2012
Recall number
Z-2010-2012
Initiated
June 21, 2012
Classification
Class II
Status
Terminated
Quantity
648 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Terumo Cardiovascular Systems has received reports of several issues that manifest themselves as communications or power failures in the system network for Terumo Advanced Perfusion System 1. Issues that affect a single pump or module are: " The appearance of a red X on a single pump or module icon on the CCM " The appearance or a single '?' symbol on a pump or module icon on the CCM " The fai

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Terumo Cardiovascular Systems has received reports of several issues that manifest themselves as communications or power failures in the system network for Terumo Advanced Perfusion System 1. Issues that affect a single pump or module are: " The appearance of a red X on a single pump or module icon on the CCM " The appearance or a single '?' symbol on a pump or module icon on the CCM " The fai

Code information

Catalog number: 801764 and serial number: 0006-0066, 0100-0311, 0313-0322, 1001-1027, 1100-1434, 1436,1440, and 1441.

Distribution pattern

Worldwide Distribution-USA (nationwide) including the states of , AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV and the countries of ARGENTINA, AUSTRALIA, BELGIUM, CANADA, CHILE, COLOMBIA, Costa Rica, Dominican Republic, Egypt, Germany, Guatemala, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, UNITED ARAB EMIRATES (UAE), and Vietnam.