Z-0317-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 13, 2024
- Initiation Date
- September 6, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30
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.
Distribution Pattern
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.
Code Information
UDI-DI: 04540217065271. Serial Numbers: MQ493E3E3001, MQ493E3E3002, MQ493E3D6002, MQ493E3D5001, MQ493E3D8002, MQ493E3E1002, MQ493E3D4002, MQ493E3D6003, MQ493E3DA002, MQ493E3E2001, MQ493E3E2002, MQ493E3E1001, MQ493E3DC001, MQ493E3D9001, MQ493E3D4005, MQ493E3D7001, MQ493E3DB002, MQ493E3D2002, MQ493E3D4001, MQ493E3D7002, MQ493E3D4003, MQ493E3D4004, MQ493E3D2001, MQ493E3D8001, MQ493E3D5002, MQ493E3DB001, MQ493E3D2003, MQ493E3DA001, MQ493E3D6001, MQ493E3E1003