FDA recall Z-2772-2020

Product

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

Worldwide distribution - US Nationwide distribution and the countries of Canada, India, Portugal, Singapore, Slovak Republic, Thailand, Turkey, UK.

Key facts

Status

Terminated

Initiation date

2020-07-15

Report date

2020-08-19

Termination date

2021-07-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Danvers, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2772-2020