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Health product recall

Bio-potential Signal Acquisition System

Starting date:
August 12, 2016
Posting date:
November 9, 2016
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
Healthcare Professionals, General Public, Hospitals
Identification number:
RA-60898

Affected Products

Reason

al signal amplifier is incorrectly labeled as a Type CF applied part. The correct labels should identify them as Type BF applied parts.

Affected products

Bio-potential Signal Acquisition System

Lot or serial number

All serial numbers

Model or catalog number

5703
5747
5748

Companies
Manufacturer
Blackrock Microsystems, LLC
630 Komas Drive, Suite 200
Salt Lake City
84108
Utah
UNITED STATES