Shimadzu Mobile X-Ray System Recalled for Brake Failure
Shimadzu is recalling 93 MobileDaRt Evolution mobile X-ray systems because the brakes may fail to engage when the operator releases the drive handle.
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 is classified as FDA Class II, and the hazard involves a mechanical failure that could lead to injury, but no injuries have been reported.
Plain-English summary
Shimadzu Medical Systems USA is recalling 93 units of the MobileDaRt Evolution (MX8 Version) mobile X-ray system. The recall is due to a defect where the system's brakes may not apply when the operator releases the drive handle. Normally, the brake is applied by letting go of the handle, but in the affected units, the device may continue to coast if the handle is released while the unit is moving.
The affected units were distributed nationwide in the United States. The recall covers specific serial numbers manufactured during a specified period, which are listed in the official recall documentation. No injuries or illnesses have been reported in connection with this defect.
Hospitals and healthcare facilities should contact Shimadzu Medical Systems USA to arrange for a repair or replacement of the affected units. Operators should be aware of the potential for the device to continue moving if the brake fails to engage.
The recalled product
- Product
- SHIMADZU MobileDaRt Evolution (MX8 Version), Mobile X-Ray System Product Usage: This 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 emergency. Exposure can be captured on film, CR…
- Manufacturer
- Shimadzu Medical Systems Usa Com
- Category
- Medical Device — Mobile X-Ray
- Affected units
- 93
Distribution
Distributed nationwide across the United States.
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