Seqex Medical Devices (2016-12-19)

Starting date:
December 19, 2016
Posting date:
February 1, 2017
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-62030

Affected Products

A. Seqex MED
B. Seqex FAM
C. Seqex HC
D. Smart Seqex
E. Field Enhancement Set
F. Hand-Held Spot Probe
G. Pro Intensive Applicator
H. Home Unit Intensive Applicator

Reason

SISTEMI SRL is notifying their customers that they do not hold a device license for the Seqex medical devices.

Affected products

A. Seqex MED

Lot or serial number

Contact manufacturer

Model or catalog number

MED

Companies
Manufacturer
SISTEMI SRL
VIA DELLE SPONE, 34, 38057 CIRE DI PERGINE
Trento
ITALY

B. Seqex FAM

Lot or serial number

Contact manufacturer

Model or catalog number

FAM

Companies
Manufacturer
SISTEMI SRL
VIA DELLE SPONE, 34, 38057 CIRE DI PERGINE
Trento
ITALY

C. Seqex HC

Lot or serial number

Contact manufacturer

Model or catalog number

HC

Companies
Manufacturer
SISTEMI SRL
VIA DELLE SPONE, 34, 38057 CIRE DI PERGINE
Trento
ITALY

D. Smart Seqex

Lot or serial number

Contact manufacturer

Model or catalog number

SMART

Companies
Manufacturer
SISTEMI SRL
VIA DELLE SPONE, 34, 38057 CIRE DI PERGINE
Trento
ITALY

E. Field Enhancement Set

Lot or serial number

Contact manufacturer

Model or catalog number

FIELD INCREASERS

Companies
Manufacturer
SISTEMI SRL
VIA DELLE SPONE, 34, 38057 CIRE DI PERGINE
Trento
ITALY

F. Hand-Held Spot Probe

Lot or serial number

Contact manufacturer

Model or catalog number

HAND-HELD SPOT

Companies
Manufacturer
SISTEMI SRL
VIA DELLE SPONE, 34, 38057 CIRE DI PERGINE
Trento
ITALY

G. Pro Intensive Applicator

Lot or serial number

Contact manufacturer

Model or catalog number

INTENSIVE PAD

Companies
Manufacturer
SISTEMI SRL
VIA DELLE SPONE, 34, 38057 CIRE DI PERGINE
Trento
ITALY

H. Home Unit Intensive Applicator

Lot or serial number

Contact manufacturer

Model or catalog number

INTENSIVE PAD

Companies
Manufacturer
SISTEMI SRL
VIA DELLE SPONE, 34, 38057 CIRE DI PERGINE
Trento
ITALY