Recall Z-0316-2025 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
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.
| Date | Nov 7, 2024 (initiated Sep 6, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Software change control |
| Action | 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 drodriguez@shimadzu-usa.com If you have questions contact the firm' |
| Quantity | 3 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190373 | SonialVision G4 Shimadzu Corporation, Mar 15, 2019 |