This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
Philips Oximetry Modules (2015-04-13)
- Starting date:
- April 13, 2015
- Posting date:
- May 1, 2015
- 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-53205
Recalled Products
A. Alice 6 - High performance/low power module
B. Masimo Oximetry Module
C. MASIMO SET-HIGH PERFORMANCE/LOW POWER MODULE
Reason
Philips has become aware that certain oximetry modules may have been incorrectly assembled. The effect on performance when these wires are crossed is that when a low SPO2 value is measured, a high SPO2 value would be displayed on the monitoring device. Additionally, in the same oximetry cable, when a high SPO2 value is measured, a low SPO2 value would be displayed on the monitoring device.
Affected products
A. Alice 6 - High performance/low power module
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
1075383
Companies
- Manufacturer
-
Philips Electronics Ltd.
281 Hillmount Road
Markham
L6C 2S3
Ontario
CANADA
B. Masimo Oximetry Module
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
1075383
Companies
- Manufacturer
-
Philips Electronics Ltd.
281 Hillmount Road
Markham
L6C 2S3
Ontario
CANADA
C. MASIMO SET-HIGH PERFORMANCE/LOW POWER MODULE
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
1075383
Companies
- Manufacturer
-
Philips Electronics Ltd.
281 Hillmount Road
Markham
L6C 2S3
Ontario
CANADA