Health product recall

Nova and TXR Nova Radiographic System (2018-08-22)

Starting date:
August 22, 2018
Posting date:
November 28, 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-68372

Affected products

  1. Nova Radiographic System
  2. TXR Nova Radiographic System

Reason

There is a potential safety problem has been detected that could lead to the breakage of the two steel cables that support the equipment to its roof anchor.

Affected products

A. Nova Radiographic System

Lot or serial number
  • 10100586
  • 10430109
  • 11020405
  • 12251004
Model or catalog number

NOVA

Companies
Manufacturer

SEDECAL SA

PELAYA 9- POLIGONO INDUSTRIAL

RIO DE JANEIRO, ALGETE, MADRID

28110

SPAIN


B. TXR Nova Radiographic System

Lot or serial number
  • 10111571
  • 10370067
  • 12251000
  • 14391003
Model or catalog number

NOVA DUAL RECEPTOR

Companies
Manufacturer

SEDECAL SA

PELAYA 9- POLIGONO INDUSTRIAL

RIO DE JANEIRO, ALGETE, MADRID

28110

SPAIN