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Health product recall

Corometrics 174 Series Monitor(2014-05-12)

Starting date:
May 12, 2014
Posting date:
June 5, 2014
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-39823

Recalled Products

Corometrics 174 Series Monitor

Reason

The affected Corometrics174 units were delivered with the incorrect FECG port label. We have identified that the Corometrics174 series products may not currently meet type CF leakage testing requirements. The products do meet testing requirement for type BF leakage limits.

Affected products

Corometrics 174 Series Monitor

Lot or serial number

SAS0725979PA to SAS14032053PA
 

Model or catalog number

Corometrics 174
 

Companies
Manufacturer
Wipro GE Healthcare Private Ltd.
No 4, Kadugodi Industrial Area
Bangalore, Karnataka
560067
INDIA