Shimadzu Recalls Mobile X-ray Systems Due to Metal Plate Cracking Risk
Shimadzu Medical Systems is recalling 56 mobile X-ray systems because a connecting metal plate may crack, posing a structural safety risk.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a structural defect (cracking metal plate) in a medical device, which meets the rubric criteria for a 'structural vehicle defect' or significant injury risk, warranting a Severe classification.
Plain-English summary
Shimadzu Medical Systems is recalling 56 units of the Mobile X-ray System, models MUX-100 and MUX-100H. These devices are used to take general radiography of patients in hospitals who cannot move and outpatients in emergency settings. The recall is due to a defect where the connecting metal plate that joins the main chassis and the column of the MUX-100 may crack.
The affected units were distributed nationwide in the USA. The specific serial numbers for the recalled units are listed in the agency's official documentation. No injuries or illnesses have been reported in the source text.
Consumers and healthcare facilities should stop using the affected devices and contact Shimadzu Medical Systems for instructions on how to proceed with the recall.
The recalled product
- Product
- Mobile X-ray System, Model: MUX-100, MUX-100H Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannnot move and/or of outpatients in emergency
- Manufacturer
- Shimadzu Medical Systems
- Affected units
- 56
Distribution
Distributed nationwide across the United States.
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