Recall Z-0379-2018— Carl Zeiss Metrology Inc
Class II · Ongoing
Class II FDA medical device recall by Carl Zeiss Metrology Inc, initiated 2017-11-14. FDA's recall record names no specific 510(k) clearance for this event. Product: Metrotom 800 (130kV CT scanner) Industrial CT scanner for measuring and inspecting complete components made of plastic or light metal.. Reason: 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..
- Recalling firm
- Carl Zeiss Metrology Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2017-11-14
- Firm location
- Maple Grove, MN, United States
Product description
Metrotom 800 (130kV CT scanner) Industrial CT scanner for measuring and inspecting complete components made of plastic or light metal.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.