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