Shimadzu Sonialvision Safire II X-ray System Recalled for Irradiation Display Error
Shimadzu Medical Systems is recalling 17 Sonialvision Safire II angiographic x-ray systems because the irradiation time and integral dose displays may reset to zero during serial radiography.
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: The recall involves a medical device defect that could lead to unintended radiation exposure or dosing errors, representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
Shimadzu Medical Systems is recalling 17 units of the Sonialvision Safire II angiographic x-ray system, Model DAR-8000f. The recall affects devices distributed in Illinois, Washington, Michigan, Texas, Arizona, California, Louisiana, Florida, South Carolina, and New Jersey.
The recall was initiated because the indicated "irradiation time" on the X-ray Generator Console and the "integral dose" on the external fluoroscopy console may reset to 0 when selecting serial radiography with a pulse rate of 7.5fps. This issue can occur when selecting a preset or changing the pulse rate using a temporary edit function. There has been one report of this event.
Hospitals and medical facilities using these devices should contact Shimadzu Medical Systems for further instructions on how to address the defect. The device is intended for use by physicians and X-ray technologists for radiography in hospital settings.
The recalled product
- Product
- Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray system device intended to be used for the radiography in the hospital with X-ray devices. This device is operated and used by the physicians and X-ray technologist. The object of this device…
- Manufacturer
- Shimadzu Medical Systems
- Affected units
- 17
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (17)
- Serial #: 0161G68101
- 0261G65303
- 0261G65702
- 0261G68204
- 3M72BFB21001
- 3M72BFB2A001
- 3M72BFC2A001
- 3M72BFC2C001
- 3M72BFB32001
- 3M72BFB32006
- 3M72BFB33003
- 3M72BFC33001
- 3M72BFC34001
- 3M72BFB35005
- 3M72BFC37002
- 3M72BFC42001
- 3M72BFB46002
Distribution
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