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U.S. Department of Health and Human Services

Class 2 Device Recall Cuattro DR Software

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  Class 2 Device Recall Cuattro DR Software see related information
Date Initiated by Firm October 15, 2019
Create Date May 08, 2020
Recall Status1 Terminated 3 on April 27, 2021
Recall Number Z-1934-2020
Recall Event ID 85446
510(K)Number K161937  
Product Classification System, x-ray, stationary - Product Code KPR
Product CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0
Code Information Product Version: 4.4.128
Recalling Firm/
Manufacturer		 Cuattro LLC
150 Capital Dr Ste 280
Golden CO 80401
For Additional Information Contact Cuattro Customer Service
1800-709-4514
Manufacturer Reason
for Recall		 There is a potential that an image from a previous patient study to show up in a later patient study. This may result in misdiagnosis of the correct patient.
FDA Determined
Cause 2		 Device Design
Action On October 15, 2019, The firm contacted all affected consignees via phone call. In addition to informing consignees about the recall. The firm provided the following information to consignees: . To prevent a reoccurrence of this problem Cuattro has updated the settings file in the program data folder on your acquisition workstation. This update to the file will prevent any backup images from being downloaded to the acquisition workstation. This was completed for your system on September 6, 2019, service ticket number 70002871
Quantity in Commerce 9 units
Distribution US: NJ, MI, SC, NC, MI, AR, OUS: None
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 = KPR and Original Applicant = Cuattro, LLC
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