Shimadzu Mobile X-ray Systems Recalled for Loose Internal Screws
Shimadzu Medical Systems is recalling 200 Mobile DaRt Evolution X-ray systems due to a potential risk of internal screws becoming loose.
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 structural defect (loose screws) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
Shimadzu Medical Systems is recalling 200 units of the Mobile DaRt Evolution mobile X-ray system. These devices are used to take general radiography of patients in hospitals who cannot move and outpatients in emergency settings. The affected units were distributed nationwide in the United States.
The recall was initiated because Shimadzu identified a potential issue in certain manufacturing lots of the Mobile DaRt Evolution when used in combination with CXDI-70C, CXDI-55C, and CXDI-55G components. An investigation revealed a potential risk for screws becoming loose inside the X-ray systems.
Hospitals and healthcare facilities should identify affected units by checking the serial numbers listed in the official recall notice. Affected serial numbers are provided for units in combination with CXDI-70C, CXDI-55C, and CXDI-55G. Users should contact Shimadzu Medical Systems for instructions on how to address the issue.
The recalled product
- Product
- Shimadzu Corporation - Mobile DaRt Evolution This device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of out patients in emergency .
- Manufacturer
- Shimadzu Medical Systems
- Hazard
- Affected units
- 200
Distribution
Distributed nationwide across the United States.
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