The Recall Desk
HighFDA (Devices)·Z-0379-2018·Announced 2018-02-07

Carl Zeiss Metrotom 800 CT Scanner Recalled for Software Error

Carl Zeiss Metrology Inc. is recalling 13 Metrotom 800 industrial CT scanners in the US and Canada due to a software error that causes the system to resume scanning automatically when the access door is closed.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (x-ray emission) where the safety mechanism is bypassed, but no injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for theoretical risk without reported harm.

Plain-English summary

Carl Zeiss Metrology Inc. is recalling 13 units of the Metrotom 800 (130kV CT scanner) in the United States and Canada. These industrial CT scanners are used for measuring and inspecting complete components made of plastic or light metal. The recall affects units distributed in the US states of Wisconsin, North Carolina, Georgia, Illinois, Arizona, Florida, California, and New Jersey, as well as Puerto Rico and Canada.

The recall is due to a software error that causes the system to automatically resume its scan cycle when the user closes the access door, rather than requiring the user to initiate x-ray generation from the control panel. This behavior deviates from the intended safety protocol where x-ray generation is manually initiated by the user.

Affected serial numbers are 152806, 157499, 157683, 181193, 181364, 182887, 186654, 186767, 186797, 192099, 192182, 192351, and 197342. Users of these devices should contact Carl Zeiss Metrology Inc. for further instructions on how to address the software error.

The recalled product

Product
Metrotom 800 (130kV CT scanner) Industrial CT scanner for measuring and inspecting complete components made of plastic or light metal.
Affected units
13

Distribution

Distributed in 8 states: