X-ray System Models Recalled for Potential Radiation Dose Exceeding Standards
Shimadzu Medical Systems recalls 176 SonialVision G4 X-ray systems that may emit radiation doses exceeding federal standards in some fluoroscopic mode cases. No injuries have been reported.
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 medical device with a technical hazard (radiation dose exceeding federal standard CFR 1020.32). Although this represents a risk of potential patient harm, no illnesses or injuries have been reported in the source text. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
Shimadzu Medical Systems is recalling 176 SonialVision G4 X-ray TV systems distributed across 36 U.S. states. The affected systems are identified by specific serial numbers listed in the recall notice.
The recalled systems may emit X-ray radiation doses that exceed the federal standard specified in CFR 1020.32 when operated in certain fluoroscopic modes. This issue is due to inadequate adjustment criteria established during equipment installation.
No patient injuries or illnesses have been reported related to this issue. Customers who have these systems should contact Shimadzu Medical Systems for instructions on remediation, which may include software updates or other corrective actions.
The recalled product
- Product
- MODEL: X-RAY TV SYSTEM SONIALVISION G4
- Manufacturer
- Shimadzu Medical Systems
- Affected units
- 176
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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