Z-2772-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 19, 2020
- Initiation Date
- July 15, 2020
- Termination Date
- July 13, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35
Product Description
OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with software version before 05.01.01 - Product Usage: is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck.
Reason for Recall
There are 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.
Distribution Pattern
Worldwide distribution - US Nationwide distribution and the countries of Canada, India, Portugal, Singapore, Slovak Republic, Thailand, Turkey, UK.
Code Information
UDI: 08806167789220; all NL5000 systems with software version before 05.01.01; Serial Numbers: 00008 00009 00010 00011 00012 00013 00016 00018 00020 00021 00022 00023 00024 00027 00030 00031 00032 00033 00035 00036 00037 00040 00043 00044 00045 00046 00007 00014 00017 00028 00034 00038 00039 00041 00042