This page has been archived on the Web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.

Health product recall

Novasure Radiofrequency Control Unit (2014-01-24)

Starting date:
January 24, 2014
Posting date:
March 19, 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-38335

Recalled Products

Novasure Radiofrequency Control Unit

Reason

Device being recalled because they do not meet a particular requirment of the electrical standard , IEC 60601-1 the which conformity is claimed.

Affected products

Novasure Radiofrequency Control Unit

Lot or serial number

33868H13DO - 34064K13DO

Model or catalog number

RFC2009-115

Companies
Manufacturer
Hologic, Inc.
250 Campus Drive
Marlborough
01752
Massachusetts
UNITED STATES