This page has been archived on the Web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.
HANDHELD PULSE OXIMETERS (2015-07-13)
- Starting date:
- July 13, 2015
- Posting date:
- August 24, 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-54736
Affected Products
A.N-560 PULSE OXIMETER
B.Nellcor N-560 Pulse Oximeter
C.N-65 HANDHELD PULSE OXIMETER
D.OXIMAX N-65 HANDHELD PULSE OXIMETER
Reason
Nellcort N-65 handheld pulse Oximeters and N-560 pulse Oximeters do not fully display segments of numeric data (see example below). This may lead to an end user's misinterpretation of the numeric data being displayed.
Affected products
A.N-560 PULSE OXIMETER
Lot or serial number
All lots
Model or catalog number
N560
Companies
- Manufacturer
-
Covidien LLC
15 Hampshire Street
Mansfield
Massachusetts
UNITED STATES
B.Nellcor N-560 Pulse Oximeter
Lot or serial number
All lots
Model or catalog number
N560
Companies
- Manufacturer
-
Covidien LLC
15 Hampshire Street
Mansfield
Massachusetts
UNITED STATES
C.N-65 HANDHELD PULSE OXIMETER
Lot or serial number
All lots
Model or catalog number
N65
Companies
- Manufacturer
-
Covidien LLC
15 Hampshire Street
Mansfield
Massachusetts
UNITED STATES
D.OXIMAX N-65 HANDHELD PULSE OXIMETER
Lot or serial number
All lots
Model or catalog number
N65P
Companies
- Manufacturer
-
Covidien LLC
15 Hampshire Street
Mansfield
Massachusetts
UNITED STATES