IGEA Fast - Multistandard System, Probe, Probe Support, Power Supply, Gel Pad, Orange Ring and Vaporizer (2017-12-14)
- Starting date:
- December 14, 2017
- Posting date:
- January 8, 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-65592
Affected Products
A. IGEA Fast Multistandard System
B. IGEA Fast Probe
C. IGEA Fast Probe Support
D. IGEA Fast Power Supply
E. IGEA Fast Gel Pad
F. IGEA Fast Orange Ring
G. IGEA Fast Vaporizer
Reason
1. The previously Health Canada approved Class II Medical Device Licence for the IGEA Fast Bone Growth Stimulator expired on Oct 10, 2016 and was not renewed by the manufacturer.
2. The labelling on the individual components within the system do not have product identifiers and do not meet the standards of a Class II device.
Affected products
A. IGEA Fast Multistandard System
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
IG4500B
Companies
- Manufacturer
-
IGEA SpA
Via Parmenide, 10/A
Carpi, Modena
41012
ITALY
B. IGEA Fast Probe
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
04.01.001
Companies
- Manufacturer
-
IGEA SpA
Via Parmenide, 10/A
Carpi, Modena
41012
ITALY
C. IGEA Fast Probe Support
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
04.01.002
Companies
- Manufacturer
-
IGEA SpA
Via Parmenide, 10/A
Carpi, Modena
41012
ITALY
D. IGEA Fast Power Supply
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
31949
Companies
- Manufacturer
-
IGEA SpA
Via Parmenide, 10/A
Carpi, Modena
41012
ITALY
E. IGEA Fast Gel Pad
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
40129
Companies
- Manufacturer
-
IGEA SpA
Via Parmenide, 10/A
Carpi, Modena
41012
ITALY
F. IGEA Fast Orange Ring
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
10529
Companies
- Manufacturer
-
IGEA SpA
Via Parmenide, 10/A
Carpi, Modena
41012
ITALY
G. IGEA Fast Vaporizer
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
10537
Companies
- Manufacturer
-
IGEA SpA
Via Parmenide, 10/A
Carpi, Modena
41012
ITALY