Health product recall

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