X-ray System Radiation Dose May Exceed Safety Limits in Some Modes
Shimadzu SonialVision safire X-ray systems may emit radiation exceeding federal limits during some fluoroscopic procedures. The manufacturer is addressing installation criteria to prevent potential dose violations.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 recall involving potential radiation dose exceeding federal standards. No illnesses or injuries have been reported, and the hazard is theoretical and conditional on specific operating modes—meeting the rubric criterion: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Shimadzu Medical Systems has recalled 12 SonialVision safire X-ray television systems distributed across 36 U.S. states. The systems may exceed the radiation dose rate specified in U.S. Code of Federal Regulations (CFR) section 1020.32 during certain fluoroscopic procedures due to inadequate adjustment criteria in the installation process.
The issue affects specific operating modes and is contingent on improper installation settings. No illnesses or injuries have been reported.
Healthcare facilities that have received these systems should contact Shimadzu Medical Systems regarding corrective installation procedures. The manufacturer is addressing the inadequate installation criteria to ensure radiation dose compliance with federal safety standards.
The recalled product
- Product
- MODEL: X-RAY TV SYSSTEM SONIALVISION safire17
- Manufacturer
- Shimadzu Medical Systems
- Hazard
- Affected units
- 12
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.
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