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LICOX Brain Tissue Oxygen Monitoring Systems (2014-11-07)
- Starting date:
- November 7, 2014
- Posting date:
- January 14, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-43285
Recalled Products
A) LICOX Micro-Probe Kit
B) LICOX Brain Tissue Oxygen Monitoring System - Complete Brain Probe Kit
C) LICOX Brain Tissue Oxygen Monitoring System - Complete Brain Tunneling Probe Kit
D) Combined Oxygen and Temperature Probe
E) Oxygen Probe
Reason
Integra Lifesciences initiated a recall to remove all affected LICOX probes and probe kits that may contain an inaccurate smart cards supplied with the subject devices. The IKN2 value in approximately 90% of the potentially affected cards is approximately 10 times higher than it should be resulting in varying degrees of understated PO2 values (from -1 mm of Hg to -7 mm of Hg) when the probes are used.
Affected products
A) LICOX Micro-Probe Kit
Lot or serial number
All lots.
Model or catalog number
IM1.S
IM3.S
IM3.ST
Companies
- Manufacturer
-
GMS-Gesellschaft Fur Medizinische Sondentechnik MBH
Dorfstrasse 2, Mielkendorf,
Kiel, Schleswig-Holstein
24247
GERMANY
B) LICOX Brain Tissue Oxygen Monitoring System - Complete Brain Probe Kit
Lot or serial number
All lots.
Model or catalog number
IP1.P
IP2.P
Companies
- Manufacturer
-
GMS-Gesellschaft Fur Medizinische Sondentechnik MBH
Dorfstrasse 2, Mielkendorf,
Kiel, Schleswig-Holstein
24247
GERMANY
C) LICOX Brain Tissue Oxygen Monitoring System - Complete Brain Tunneling Probe Kit
Lot or serial number
All lots.
Model or catalog number
IT2
Companies
- Manufacturer
-
GMS-Gesellschaft Fur Medizinische Sondentechnik MBH
Dorfstrasse 2, Mielkendorf,
Kiel, Schleswig-Holstein
24247
GERMANY
D) Combined Oxygen and Temperature Probe
Lot or serial number
All lots.
Model or catalog number
CC1.P1
Companies
- Manufacturer
-
GMS-Gesellschaft Fur Medizinische Sondentechnik MBH
Dorfstrasse 2, Mielkendorf,
Kiel, Schleswig-Holstein
24247
GERMANY
E) Oxygen Probe
Lot or serial number
All lots.
Model or catalog number
CC1.SB
Companies
- Manufacturer
-
GMS-Gesellschaft Fur Medizinische Sondentechnik MBH
Dorfstrasse 2, Mielkendorf,
Kiel, Schleswig-Holstein
24247
GERMANY