Chartr EP 200 (2019-06-14)
- Starting date:
- June 14, 2019
- Posting date:
- July 5, 2019
- 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-70361
Last updated: 2019-07-05
Affected Products
Chartr EP 200
Reason
It has been determined that the device does not fully meet current regulatory standard for basic electrical safety and essential performance. There is a potential risk to the healthcare professional or patient of exposure to electrical shock.
Affected products
Chartr EP 200
Lot or serial number
All lots.
Model or catalog number
TYPE 1073
Companies
- Manufacturer
-
NATUS MEDICAL DENMARK APS D.B.A. GN OTOMETRICS A/S
HOERSKAETTEN 9
TAASTRUP
2630
DENMARK