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U.S. Department of Health and Human Services

Class 2 Device Recall GMR40

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  Class 2 Device Recall GMR40 see related information
Date Initiated by Firm January 12, 2018
Create Date April 17, 2018
Recall Status1 Terminated 3 on August 14, 2018
Recall Number Z-1391-2018
Recall Event ID 79628
510(K)Number K171085  
Product Classification Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
Product Solid state x-ray imager (flat panel/digital imager)

Solid state x-ray imager (flat panel/digital imager)
Medical
Code Information Model Number GMR40. Serial numbers 00001 through 00016.
Recalling Firm/
Manufacturer		 NeuroLogica Corporation
14 Electronics Ave
Danvers MA 01923-1011
For Additional Information Contact
978-564-8503
Manufacturer Reason
for Recall		 While transporting the portable machine with the retrofit equipment in a backwards motion, there is potential for foot injury from the underside of the detector bin of the retrofit unit.
FDA Determined
Cause 2		 Device Design
Action A field safety notice was sent stating that the manufacturer, without charge, will remedy the defect. The notice stated that field upgrades would be performed by December 31, 2017. The notice provided instructions to end users and to distributors. For further questions, please call (978) 564-8503.
Quantity in Commerce 16 units
Distribution US Distribution . Only one consignee was shipped 16 units of the affected device.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MQB and Original Applicant = NeuroLogica Corporation, a Subsidiary of
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