Health product recall

OmniTom (2020-07-16)

Starting date:
July 16, 2020
Posting date:
August 14, 2020
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-73685

Last updated: 2020-08-14

Affected Products

OmniTom

Reason

Neurologica Corporation has recently become aware of potential issues related to the operational state of the scanner, specifically for transport and inadvertent system shutdowns. There could be a possibility of potential delay in patient treatment if proper use instructions are not followed.

Affected products

OmniTom
Lot or serial number

All (version before 05.01.01)

Model or catalog number

NL5000

Companies
Manufacturer
NeuroLogica Corporation a subsidiary of Samsung Electronics Co. Ltd.
14 ELECTRONICS AVENUE
DANVERS
01923-1011
Massachusetts
UNITED STATES