Shimadzu Mobile X-Ray System Recalled for Improper Handle Bolts
Shimadzu Medical Systems is recalling 115 Mobile X-Ray Systems because the adjustable handle may have improper bolts, posing a risk of harm to individuals around the device.
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: The recall involves a risk-of-harm product (improper driving operation leading to harm) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
Shimadzu Medical Systems is recalling 115 units of the Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with the adjustable handle option. The devices were distributed nationwide in the United States, including in states such as Alabama, Arizona, California, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Michigan, Minnesota, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, and Wisconsin.
The recall is due to a potential issue where the adjustable handle option may have been installed with improper bolts. This defect could result in improper driving operation of the device, which could lead to harm of individuals around the device. The source text does not report any specific injuries or illnesses associated with this defect.
Healthcare facilities and users should identify their devices by checking the serial numbers listed in the recall notice. Affected units should be removed from service and the manufacturer contacted for further instructions on repair or replacement.
The recalled product
- Product
- Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjustable handle option, Made in Japan - Product Usage: The device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergen
- Manufacturer
- Shimadzu Medical Systems
- Affected units
- 115
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 (20)
- SMS ID / Serial Number SMS20200126 41F41E7A3011
- SMS20200182 41F41E7A5006
- SMS20200184 41F41E7A5008
- SMS20180073 41F41DD7C006
- SMS20180068 41F41DD7C003
- SMS20180075 41F41DD7C007
- SMS20180349 41F41DD85007
- SMS20180350 41F41DD85009
- SMS20180351 41F41DD86007
- SMS20180448 41F41DD88001
- SMS20190308 41F41E798002
- SMS20190335 41F41E799002
- SMS20190383 41F41E79A010
- SMS20200033 41F41E79B001
- SMS20200034 41F41E79B005
- SMS20200219 41F41E7A6012
- SMS20200301 41F41E7A6051
- SMS20200339 41F41E7A7006
- SMS20190016 41F41DD88010
- SMS20190138 41F41DD8B007
Distribution
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