Recall Z-0317-2025— SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Class II · Ongoing
Class II FDA medical device recall by SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION, initiated 2024-09-06. It names one FDA 510(k) clearance: K191877. Product: 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.. 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..
- Recalling firm
- SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-09-06
- Firm location
- Kyoto, N/A, Japan
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.