CLASS II ONGOING Device recall · Reported 7 Feb 2018 · FDA Enforcement Report
Metrotom 800 (130kV CT scanner) Industrial CT scanner recalled
Carl Zeiss Metrology is recalling Metrotom 800 (130kV CT scanner) Industrial CT scanner for measuring and inspecting, distributed in 9 states. The recall was initiated on 14 Nov 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0379-2018
- FDA event ID
- 78885
- Recalling firm
- Carl Zeiss Metrology, Maple Grove, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 14 Nov 2017
- FDA classified
- 26 Jan 2018
- Reported
- 7 Feb 2018
- Type
- FDA Mandated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 14 Nov 2017 | Recall initiated by company | |
| 26 Jan 2018 | Classified by FDA | +73 days |
| 7 Feb 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to a software error, it was observed that when the user closes the access door, the system will resume its scan cycle automatically, instead of the user initiating x-ray generation from the control panel.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Metrotom 800 (130kV CT scanner) Industrial CT scanner for measuring and inspecting complete components made of plastic or light metal.
Where it was distributed
Worldwide Distribution - US, including the states of : WI, NC, GA, IL, AZ, FL, CA, NJ, and territory of PR; and the country of Canada.
ArizonaCaliforniaFloridaGeorgiaIllinoisNorth CarolinaNew JerseyPuerto RicoWisconsin
Questions about this recall
Why was it recalled?
Due to a software error, it was observed that when the user closes the access door, the system will resume its scan cycle automatically, instead of the user initiating x-ray generation from the control panel.
Which lots are affected?
Serial Numbers: 152806 157499 157683 181193 181364 182887 186654 186767 186797 192099 192182 192351 197342
Where was it sold?
Worldwide Distribution - US, including the states of : WI, NC, GA, IL, AZ, FL, CA, NJ, and territory of PR; and the country of Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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