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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- Manufacturer
- Carl Zeiss Metrology Inc
- Affected units
- 13
Distribution
Related recalls
Other medical device recalls
- ModerateDRG Sperm Ab ELISA Recalled for Potential False Negative Results
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Assembly Disconnect Risk
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls 23 ABD Hysterectomy Kits Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls GYN Laparoscopy Kits for Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateSiemens CT Scanner Recall Due to Software Issue in Dual Spiral Mode
FDA (Devices) · 2019-05-08
- HighCanon PET-CT Scanner Recalled for Software Malfunction Causing Scan Failures
FDA (Devices) · 2021-10-27
- HighNeusoft NeuViz 128 CT Scanner Software Defect Recall
FDA (Devices) · 2017-09-06
- ModerateNeuViz 128 CT Scanner Recalled for Potential Image Field of View Error
FDA (Devices) · 2019-02-13
- HighSiemens SOMATOM Perspective 16 CT Scanner Recalled for Software Issue
FDA (Devices) · 2018-08-08
- ModerateNeusoft NeuViz 128 CT Scanner Recalled for Software Defect
FDA (Devices) · 2019-05-29