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

Hazard

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.

Details from the source

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: 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. Quantity: 30 Lot/code info: 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

UPC codes

04540217065271

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.