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Health product recall

Vitrea Software DVD

Starting date:
March 26, 2013
Posting date:
April 25, 2013
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-28493

Recalled Products

  1. Vitrea2
  2. Vitrea Software Dvd
  3. Vitrea Fx Software Dvd
  4. Vitrea Advanced Software Dvd
  5. Vitrea Fx Advanced Software Dvd

Reason

Product labelling deficiency on Brain Profusion Scan may cause confusion resulting in patient treatment delay, misdiagnosis or mistreatment.

Affected products

A. Vitrea2

Lot or serial number
  • Software version 5.2 and earlier
Model or catalog number
  • More than 10 numbers, contact manufacturer
Companies
Manufacturer
Vital Images Inc.
300 - 5850 Opus Parkway
Minnetonka
55343
Minnesota
UNITED STATES

B. Vitrea Software Dvd

Lot or serial number
  • Software version 5.2 and earlier
Model or catalog number
  • More than 10 numbers, contact manufacturer
Companies
Manufacturer
Vital Images Inc.
300 - 5850 Opus Parkway
Minnetonka
55343
Minnesota
UNITED STATES

C. Vitrea Fx Software Dvd

Lot or serial number
  • Software version 5.2 and earlier
Model or catalog number
  • VPMC-12253
  • VPMC-12325
  • VPMC-12396
  • VPMC-12509
  • VPMC-12193
Companies
Manufacturer
Vital Images Inc.
300 - 5850 Opus Parkway
Minnetonka
55343
Minnesota
UNITED STATES

D. Vitrea Advanced Software Dvd

Lot or serial number
  • Software version 5.2 and earlier
Model or catalog number
  • VPMC-12193
  • VPMC-12254
  • VPMC-12322
  • VPMC-12393
  • VPMC-12506
Companies
Manufacturer
Vital Images Inc.
300 - 5850 Opus Parkway
Minnetonka
55343
Minnesota
UNITED STATES

E. Vitrea Fx Advanced Software Dvd

Lot or serial number
  • Software version 5.2 and earlier
Model or catalog number
  • VPMC-12192
  • VPMC-12255
  • VPMC-12323
  • VPMC-12394
  • VPMC-12507
Companies
Manufacturer
Vital Images Inc.
300 - 5850 Opus Parkway
Minnetonka
55343
Minnesota
UNITED STATES

Date modified: