Fujifilm FDR Go PLUS Mobile X-Ray System Recalled for Braking Defect
Fujifilm is recalling 56 mobile X-ray systems because the braking mechanism may fail to engage when the handle is released.
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 in a medical device where the braking mechanism may fail, posing a risk of harm to patients or staff, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Fujifilm Medical Systems U.S.A., Inc. is recalling 56 units of the FDR Go PLUS Mobile X-Ray System. The recall was initiated after the company became aware that the braking mechanism might not be engaged in all cases when the driving handle has been released.
The affected devices are intended for taking radiography of patients in hospitals who cannot move and for outpatients in emergency settings. The recall covers units with serial numbers MQ0001281001 through MQ0001285004 that were distributed nationwide in the United States.
The source text does not specify specific instructions for consumers or healthcare facilities regarding the immediate handling of these devices, nor does it report any injuries or illnesses associated with the defect.
The recalled product
- Product
- Fujifilm FDR Go PLUS, 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 or Digital Radiography (
- Manufacturer
- Fujifilm Medical Systems U.S.A., Inc.
- Category
- Medical Device — Mobile X-Ray
- Affected units
- 56
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 (1)
- Serial Numbers: MQ0001281001 through MQ0001285004
Distribution
Distributed nationwide across the United States.
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