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U.S. Department of Health and Human Services

Class 2 Device Recall Metrotom 800

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 Class 2 Device Recall Metrotom 800see related information
Date Initiated by FirmNovember 14, 2017
Create DateJanuary 26, 2018
Recall Status1 Open3, Classified
Recall NumberZ-0379-2018
Recall Event ID 78885
Product Classification Cabinet x-ray, industrial - Product Code RCE
ProductMetrotom 800 (130kV CT scanner) Industrial CT scanner for measuring and inspecting complete components made of plastic or light metal.
Code Information Serial Numbers:  152806 157499 157683 181193 181364 182887 186654 186767 186797 192099 192182 192351 197342
Recalling Firm/
Manufacturer		 Carl Zeiss Metrology Inc
6250 Sycamore Ln N
Maple Grove MN 55369-6310
For Additional Information ContactScott Chapman
763-203-4267
Manufacturer 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.
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
ActionZeiss sent an Safety Notice Letter dated September 28, 2017, to the customers advising them of the recall. The affected device was identified as well as the issue involved. Customers are to complete and return the confirmation- waiver form. During the next scheduled service event, a ZEISS field service technician will update the Metrotom operating system. The corrections are to be made free of charge, and will be completed by March 2018. CDRH approves the CAP subject to the following conditions: Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. For further questions, please call (763) 203-4267.
Quantity in Commerce13 US
DistributionWorldwide Distribution - US, including the states of : WI, NC, GA, IL, AZ, FL, CA, NJ, and territory of PR; and the country of Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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