This page has been archived on the Web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.

Health product recall

TECAN FREEDOM EVO ( 2015-05-31)

Starting date:
May 31, 2015
Posting date:
August 10, 2015
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-54520

Affected Products

  • A. FREEDOM EVO 200
  • B. FREEDOM EVO 100
  • C. FREEDOM EVO 150

Reason

Tecan detected a software bug that manifests itself when a specific set of conditions are met. This results in the door locks unlocking potentially allowing access for an operator to reach in while the arms are moving. This could potentially cause an injury to the operator if they are physically inside the freedom EVO’s working area during arm movement.

Affected products

A. FREEDOM EVO 200

Lot or serial number
  • 1307003117
  • 1310005125
  • 810004015
  • 810004019
Model or catalog number
  • 10641200
  • 30020020
Companies
Manufacturer
Tecan Schweiz AG
Seestrasse 103
Mannedorf
8708
SWITZERLAND

B. FREEDOM EVO 100

Lot or serial number
  • 1307002389
  • 1401008002
  • 1402002590
  • 1404001427
  • 1408005343
  • 1501007609
  • 1502003851
Model or catalog number
  • 10641100
  • 30020010
Companies
Manufacturer
Tecan Schweiz AG
Seestrasse 103
Mannedorf
8708
SWITZERLAND

C. FREEDOM EVO 150

Lot or serial number
  • 1303000035
  • 1307000975
  • 911002918
Model or catalog number
  • 10641150
  • 30020015
  • 30087806
Companies
Manufacturer
Tecan Schweiz AG
Seestrasse 103
Mannedorf
8708
SWITZERLAND