SONIALVISION 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.
Recall
- Recall Number
- Z-0316-2025
- Event Number
- 95450
- Firm
- SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku
- FEI Number
- 3002808139
- Product Code
- JAA
- Status
- Open, Classified
- Root Cause
- Software change control
- Initiated
- September 6, 2024
- Posted
- November 7, 2024
- Address
- 1 Kyoto Japan
Description
SONIALVISION 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.
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.
On 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 [email protected] If you have questions contact the firm's National Technical Support at 844-487-2767, available 8:00AM-5:00PM, Monday - Friday.
US 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.
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