Health product recall

Systeme d'imagerie CryoVizion (2018-07-06)

Starting date:
July 6, 2018
Posting date:
July 6, 2018
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-67178

Affected products

Systeme d'imagerie CryoVizion

Reason

No labeling is present on the imaging column to indicate that it can tip over if supported or mounted on, as required by IEC 60601-1 ed. 3.1 (section 9.4.2.3)

Affected products

Systeme d'imagerie CryoVizion

Lot or serial number

All serial numbers.

Model or catalog number

224285

Companies
Manufacturer
Cryos Technologies
385 Rue de Salaberry
Joliette
J6E 4G4
Quebec
CANADA