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U.S. Department of Health and Human Services

Class 2 Device Recall Sedecal NOVA FA DR System

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  Class 2 Device Recall Sedecal NOVA FA DR System see related information
Date Initiated by Firm July 18, 2018
Create Date November 20, 2018
Recall Status1 Open3, Classified
Recall Number Z-0488-2019
Recall Event ID 81377
510(K)Number K133782  
Product Classification Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
Product Sedecal NOVA FA DR System. for diagnostic radiography.
Code Information Serial Numbers 07360816 through 17291024
Recalling Firm/
Manufacturer		 Sedecal S.A.
Pol. Industrial Rio De Janiero
Calle Pelaya 9-13
Algete Spain
Manufacturer Reason
for Recall		 A safety problem with installation and maintenance could lead to the breakage of the two steel cables that support the equipment to its roof anchor. Due to this, the equipment may fall and cause harm to the patient, user, or third parties.
FDA Determined
Cause 2		 Device Design
Action Initial communication from SEDECAL to all our distributors was performed on 07/18/2018 by email. The letter explained the problem and requested the consignee cease use of the unit if they observe an abnormal displacement in the vertical axis or any suspicious noise during the vertical movement.
Quantity in Commerce 145 units
Distribution US and Canada
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = MQB and Original Applicant = SEDECAL SA
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