Recall Z-0317-2025 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
The FLUOROspeed is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. FLUOROspeed may be used for emergency treatment on an outpatient basis, as well as for bedside examinations.
| 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 | 30 |
| 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
| K191877 | FLUOROspeed Shimadzu Corporation, Aug 5, 2019 |