Rappel de produits de santé

Pristina Serena (SenoAxys) (2019-05-19)

Starting date:
May 19, 2019
Posting date:
May 31, 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-70077

Last updated: 2019-05-31

Affected Products

Pristina Serena (SenoAxys)

Reason

If the Senographe Pristina gantry is rotated and the biopsy positioner is attached, the angulation angle may unexpectedly change during a motorized angulation motion, due to insufficient brake performance. This issue could result in injury to the patient's breast.

Affected products

Pristina Serena (SenoAxys)

Lot or serial number
  • 737211BU3
  • 739178BU2
Model or catalog number

7201138

Companies
Manufacturer

GE Medical Systems SCS

283 Rue De La Miniere

Buc

78530

FRANCE