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U.S. Department of Health and Human Services

Class 2 Device Recall SonialVision G4

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 Class 2 Device Recall SonialVision G4see related information
Date Initiated by FirmSeptember 06, 2024
Date PostedNovember 07, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0316-2025
Recall Event ID 95450
510(K)NumberK190373 
Product Classification System, x-ray, fluoroscopic, image-intensified - Product Code JAA
ProductSONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and fluoroscopic examinations, including general radiography and pediatric examinations, excluding mammography.
Code Information UDI-DI: 04540217064809, 04540217064816. Serial Numbers: 41C3518D7001, 41C3518E4001, 41C3536D9001
Recalling Firm/
Manufacturer		 SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Nishinokyo Kuwabara -Cho
Nakagyo-Ku; 1
Kyoto Japan
For Additional Information Contact
8175823-1305
Manufacturer Reason
for Recall		X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to Radiography mode, which may lead to the possibility of delay or cancellation of the examination.
FDA Determined
Cause 2		Software change control
ActionOn 9/13/24, recall notices were emailed to consignees asking them to do the following: 1) If the problem occurs it is possible to solve this problem by turning off the power of the system and then pushing the reset switch on the Digital radiography unit s control cabinet. 2) Your firm authorized service representative will be contacting to schedule the implementation of the corrective action but if you are not contacted, contact the firm's National Support. 3) Complete and return the response form via email to response to drodriguez@shimadzu-usa.com If you have questions contact the firm's National Technical Support at 844-487-2767, available 8:00AM-5:00PM, Monday - Friday.
Quantity in Commerce3
DistributionUS Nationwide distribution in the states of CA, CT, MA, WV, OH, NY, IA, NE, MN, IL, FL, NC, HI, LA, MD, MT, WA, AR, TX, TN, CO.
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.
510(K) Database510(K)s with Product Code = JAA
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