X-ray fluoroscopy system may deliver excessive radiation dose
Shimadzu FLUOROspeed X1 fluoroscopy systems may deliver radiation doses exceeding federal regulatory limits in specific fluoroscopic operating modes due to inadequate installation adjustment criteria.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall addressing a risk-of-harm condition where radiation doses may exceed federal safety limits in specific operating modes. No injuries or illnesses have been reported in the recall announcement.
Plain-English summary
Shimadzu Medical Systems is recalling 25 FLUOROspeed X1 x-ray fluoroscopy systems distributed across the United States. The systems may deliver radiation doses exceeding the limits specified in Code of Federal Regulations section 1020.32 when operated in fluoroscopic mode under certain conditions.
The issue stems from inadequate adjustment criteria provided during system installation. This can result in improper configuration that allows radiation dose rates to exceed regulatory limits in specific fluoroscopic mode cases.
Healthcare facilities with affected systems should contact Shimadzu Medical Systems for corrective instructions. Affected serial numbers include: MQ493E19C001, MQ493E3B8002, MQ493E3B9001, MQ493E1B4001, MQ493E1A1003, MQ493E1A3001, MQ493E1B5001, MQ493E3B8001, MQ493E1A5001, MQ493E1A1005, MQ493E1A2001, MQ493E1A4001, MQ493E1B6002, MQ493E1A8001, MQ493E1B4002, MQ493E1A4003, MQ493E1A4002, MQ493E1B6001, MQ493E1A2002, MQ493E1AC001, MQ493E1A1002, MQ493E19C002, MQ493E1A3003, MQ493E1A1004, MQ493E1A3002.
The recalled product
- Product
- MODEL: X-RAY R/F SYSTEM FLUOROspeed X1
- Manufacturer
- Shimadzu Medical Systems
- Hazard
- radiation-overdose
- installation-defect
Distribution
Distributed in 37 states:
- AK
- AR
- AZ
- CA
- CO
- CT
- FL
- GA
- IA
- ID
- IL
- IN
- KS
- KY
- LA
- MA
- MI
- MN
- MO
- MS
- MT
- NC
- NE
- NJ
- NM
- NV
- NY
- OH
- OR
- PA
- RI
- SC
- SD
- TN
- TX
- WA
- WV
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