Health product recall

iGUIDE Tracking System (2019-06-20)

Starting date:
June 20, 2019
Posting date:
July 5, 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-70371



Last updated: 2019-07-05

Affected Products

iGUIDE Tracking System

Reason

The iGUIDE Software misinterprets the 3D position tolerances limits when in Windows 7 settings the decimal point is configured as a comma.

Affected products

iGUIDE Tracking System

Lot or serial number
  • Version 2.2.0
  • Version 2.2.1
  • Version 2.2.2
Model or catalog number
  • P10602-202
  • P10602-505
Companies
Manufacturer

Medical Intelligence Medizintechnik Gmbh

Robert-Bosch-Strasse 8

Schwabmunchen

86830

GERMANY