The FLUOROspeed is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studie
FDA device recall Z-0317-2025 · posted 2024-11-07 · Open, Classified
Recall details
- Recalling firm
- SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
- 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.
- Action taken
- 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's National Technical Support at 844-487-2767, available 8:00AM-5:00PM, Monday - Friday.
- Root cause
- Software change control
- Status
- Open, Classified
- Product code
- JAA
- Quantity affected
- 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.
- Date initiated
- 2024-09-06
- Date posted
- 2024-11-07
- Location
- Kyoto, Japan
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FLUOROspeed (K191877) | Shimadzu Corporation | 2019-08-05 |