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Health product recall

IPLAN! RT IMAGE PLATFORM SOFTWARE (2015-09-07)

Starting date:
September 7, 2015
Posting date:
February 8, 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-57010

Affected Products

IPLAN! RT IMAGE PLATFORM SOFTWARE

Reason

For use in Brainlab software, image sets other than CT must only contain the same pixel values calibration for all images/slices of the set.

Affected products

IPLAN! RT IMAGE PLATFORM SOFTWARE

Lot or serial number

Version below v.4.1.2

Model or catalog number
  • 20143B
  • 20143C
  • 20144
  • 20146
  • 20147
  • 20148
  • 20149
  • 21211
  • 21211(3.0)
  • 21211-01
  • 21211A
  • 21211D (4.1)
  • 21211E
  • 21384
  • 21386
  • 21386A
  • 70210
  • 70210A
  • 70210B
  • 70210C
  • 70210D
  • 70211
  • 70211B
  • 70227
  • 70229
  • 70229A
  • 70229B
  • 70236
  • 70239
  • 70298
  • 70299
  • 71211C
Companies
Manufacturer
Brainlab AG
Kapellenstr 12
Feldkirchen
85622
GERMANY

Date modified: