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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 Softwaresee related information
Date Initiated by FirmOctober 15, 2019
Create DateMay 08, 2020
Recall Status1 Terminated 3 on April 27, 2021
Recall NumberZ-1934-2020
Recall Event ID 85446
510(K)NumberK161937 
Product Classification System, x-ray, stationary - Product Code KPR
ProductCuattroDR 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 ContactCuattro 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
ActionOn 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 Commerce9 units
DistributionUS: NJ, MI, SC, NC, MI, AR, OUS: None
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KPR
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