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Protektor IOM and Protektor 32 System (2014-10-29)
- Starting date:
- October 29, 2014
- Posting date:
- November 28, 2014
- 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-42709
Recalled Products
A) Protektor IOM system
B) Protektor 32 System
Reason
When using remote monitoring with local acquisition system configured to block remote acquisition changes, if the remote user tries to stop the free run waveform group, the system will display a message informing the user that they do not have sufficient privilege to perform this action.
Affected products
A) Protektor IOM system
Lot or serial number
PRACQ0103C8-S
PRACQ0108C9-S
PRACQ0120D3-S
PRACQ0438E
Model or catalog number
10271
Companies
- Manufacturer
-
Natus Medical Incorporated DBA Excel-Tech Ltd (XLTEK),
2568 Bristol Circle,
Oakville,
L6H 5S1
Ontario
CANADA
B) Protektor 32 System
Lot or serial number
00298000102B
0029800157B
0029800164B
0029800176B
002980B20291
002980B20292
002980B20355
Model or catalog number
002980
Companies
- Manufacturer
-
Natus Medical Incorporated DBA Excel-Tech Ltd (XLTEK),
2568 Bristol Circle,
Oakville,
L6H 5S1
Ontario
CANADA