This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
Keypoint System - EP Amplifier (Headbox) (2015-11-01)
- Starting date:
- November 1, 2015
- Posting date:
- February 1, 2016
- 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-56886
Affected Products
KEYPOINT SYSTEM - EP AMPLIFIER (HEADBOX)
Reason
The channel configuration in the EP amplifier is not always fully restored when returning to the waveform display. Intermittently the effected channel (s) becomes disconnected from the EP amplifier input pins, leaving the input signal floating. The results in no curve displayed or the displayed curve (s) becoming distorted (noisy, unstable).
Affected products
KEYPOINT SYSTEM - EP AMPLIFIER (HEADBOX)
Lot or serial number
- Version 2.31 - 2.32 software
Model or catalog number
- 9031C077_
Companies
- Manufacturer
-
Alpine Biomed Aps
Tonsbakken 16-18
Skovlunde