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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