Central Control Module for System 1: System 1 Base recall
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…
Why was Central Control Module for System 1: System 1 Base recalled?
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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog number: 801763 and serial numbers: 0011-0335, 0337-0610,1001-1034, 1037-1049, 1100, 1103-1106, 1109-1445, and 1447-1450.
- 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…
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- 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.
- Recall date
- July 18, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)