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
- Affected units
- 25
Distribution
Part of a larger recall action
This product is one of 3 recalled by Shimadzu Medical Systems under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Shimadzu Medical Systems
See all →- HighDigital angiography and radiography systems may remain energized when switched off
FDA (Devices) · 2026-06-10
- HighX-ray System Radiation Dose May Exceed Safety Limits in Some Modes
FDA (Devices) · 2022-04-13
- HighX-ray System Models Recalled for Potential Radiation Dose Exceeding Standards
FDA (Devices) · 2022-04-13
- HighDigital Angiography System generator may exceed safe radiation dose rates
FDA (Devices) · 2022-03-09
- HighDigital Angiography System Generators May Emit Excessive X-Ray Radiation
FDA (Devices) · 2022-03-09
Same hazard · radiation overdose
See all →- HighX-Ray System Recalled for Potential Excessive Radiation Dose in First Image
FDA (Devices) · 2025-02-05
- HighSiemens ARTIS Angiography Systems May Deliver Unintended Radiation Doses
FDA (Devices) · 2024-07-10
- HighARTIS Angiography Systems Recalled for Potential Radiation Overdose
FDA (Devices) · 2024-07-10
- HighRadiation therapy planning system may report overly high skin surface doses
FDA (Devices) · 2024-05-08
- HighProton Therapy System Delivers Incorrect Radiation Dose in First Layer
FDA (Devices) · 2022-06-08