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Health product recall

INGENUITY CT SYSTEM (2015-04-22)

Starting date:
April 22, 2015
Posting date:
October 14, 2015
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-55328

Affected Products

INGENUITY CT SYSTEM

Reason

During a contact renewal the provider of the antivirus software discovered that the current software version was due to expire on February 15, 2015. With the expiration on February 15, 2015 this left the systems with no active virus protection which does not meet the product performance specification. It is important to note that systems will function as intended once the software expires.

Affected products

INGENUITY CT SYSTEM

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

728321
728323
728326

Companies
Manufacturer
Bayer Medical Care Inc.
1 Bayer Drive
Indianola
15051-0780
Pennsylvania
UNITED STATES