This page has been archived on the Web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.
Corometrics 170 Series Monitors (2015-05-04)
- Starting date:
- May 4, 2015
- Posting date:
- June 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-53557
Recalled Products
- Corometrics 170 Series Monitors
Reason
Some of the Corometrics 171, 172, 173 and 174 series monitors were delivered with the FHR lower alarm limit configured incorrectly at 50 BPM (proper factory default setting is 120 BPM). A lower than expected FHR, if left undetected, could result in fetal bradycardia and oxygen deprivation to the fetus. There have been no injuries reported as a result of this issue.
Affected products
A. Corometrics 170 Series Monitors
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
Not applicable
Companies
- Manufacturer
-
Wipro GE Healthcare Private Ltd.
No 4
Kadugodi Industrial Area
560067
INDIA