Terumo Advanced Perfusion System 1 Power Manager Board (2018-11-13)
- Starting date:
- November 13, 2018
- Posting date:
- January 8, 2019
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-68674
Affected products
Terumo Advanced Perfusion System 1 Power Manager Board
Reason
During internal testing, Terumo CVS identified that screws on a Terumo Advanced Perfusion System 1 Power Manager Board (the base unit circuit board) were not torqued to specification. It is possible that a screw which is not properly torqued can loosen over time resulting in an electrical short.
Affected products
Terumo Advanced Perfusion System 1 Power Manager Board
Lot or serial number
1559,1567
Model or catalog number
- 801763
Companies
- Manufacturer
-
Terumo Cardiovascular Systems Corp.
6200 Jackson Road
Ann Arbor
48103
Michigan
UNITED STATES