SCP Pump Control Panel (2019-08-26)
- Starting date:
- August 26, 2019
- Posting date:
- September 6, 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-70911
Last updated: 2019-09-06
Affected Products
SCP Pump Control Panel
Reason
The affected angle encoders may present with premature wear of the encoder shaft leading to difficult or impossible rotation.When this issue occurs on the SCP system control panel, the speed control knob appears blocked or stiff and/or does not appear to be controlling the drive unit. The loss of function of the angle encoder during bypass may result in an inability to set the intended flow rate leading more or less blood flow than intended.
Affected products
SCP Pump Control Panel
Lot or serial number
60S14733
Model or catalog number
1960-02-15
60-02-50
Companies
- Manufacturer
-
Livanova Deutschland GmbH
Lindberghstrasse 25
Munich
80939
GERMANY