FDA Medical Device Recalls (openFDA)
Terumo Cardiovascular Systems Corporation: Central Control Module for 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.
- Recall number
- Z-1957-2012
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Product
- Central Control Module for 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.
- Status
- Terminated
- Initiated
- 2012-06-22
- Posted
- 2012-07-06
- Terminated
- 2013-03-06
- Reason
- Terumo CVS has received reports of the Central Control Monitor (CCM) for Terumo Advanced Perfusion System 1 losing partial or full functionality. Symptoms that have been associated with a malfunctioning CCM include: full or partial loss of display, loss of control functions; inability to distinguish various status, alert, alarm conditions, the inability to operate the touch screen, or the CCM
- Root cause
- Device Design
- Action
- The firm, TERUMO, sent an "URGENT MEDICAL DEVICE RECALL" notice dated June 22, 2012 and addendum to the Operator's Manual via Federal Express to its customers. The letter described the product, problem and actions to be taken. The notice states to the customers "Please note that we are not recommending that you stop using your Central Control Monitor". The customers were instructed to review the Medical Device Recall notice; assure that all users are aware of this notice; place the Addendum at the beginning of the Central Control Monitor Section (page 4-1) of the Operator's Manual and complete and return the attached Customer Response Form to the fax number indicated on the form. If you have any questions or concerns, contact Terumo CVS Customer Service at 1-800-521-2818; customer service hours are from Monday-Friday, 8 AM - 6 PM ET.
- Quantity
- 992 units
- Distribution
- Worldwide distribution: USA (nationwide) and countries including: Argentina, 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.
- Lot, serial or model codes
- Catalog number: 801763 and serial numbers: 0011-0335, 0337-0610,1001-1034, 1037-1049, 1100, 1103-1106, 1109-1445, and 1447-1450.
- 510(k) numbers
- ["K022947"]
- PMA numbers
- not on file
- Product code
- DTQ
- Firm FEI
- 1828100
- Firm city
- Ann Arbor
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28