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Health product recall

Medrad Stellant with Certegra Workstation(2014-05-01)

Starting date:
May 1, 2014
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-39495

Recalled Products

Medrad Stellant with Certegra Workstation

Reason

A RF suppression ferrite has to be added to the Ethernet cable to consistently reduce emissions below the allowed limit for the Stellant D Dual syringe injector with Certegra Workstation, causing a misbranding of the product.

Affected products

Medrad Stellant with Certegra Workstation

Lot or serial number

SN 10409, 10430, 11036
SN 10493, 10478, 10473
SN 11047
SN 11295, 10962, 10516

Model or catalog number

SCT-310

Companies
Manufacturer
Medrad Inc.
One Medrad Drive,
Indianola
15051-0780
Pennsylvania
UNITED STATES