Digital X-ray System Arm May Break, Posing Injury Risk
FUJIFILM's FDR AQRO digital X-ray system arm may break during use. The tube head support is susceptible to failure, which could cause serious harm to patients or operators.
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: This is an FDA Class II medical device recall involving risk of serious injury from structural failure. The source does not report any illnesses or injuries; the hazard is potential rather than realized. Per the rubric, risk-of-harm products where injury has not yet been reported warrant a High severity score.
Plain-English summary
FUJIFILM Healthcare Americas Corporation is recalling the FDR AQRO Model DR-XD1000, a digital mobile X-ray system intended for general purpose radiography of adults, pediatric, and neonatal patients. The arm that holds the tube head in place is susceptible to breaking.
If the arm breaks during use, it could potentially cause serious harm or injury to patients or operators. The tube head assembly's structural integrity is critical to safe operation, as the arm positions and holds the X-ray source during imaging procedures.
Seventy-seven units of this device have been distributed nationwide. The affected devices are identified by UDI (01)04547410425505(11)200701, with serial numbers ending between 0001 and 1993.
The recalled product
- Product
- FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams
- Manufacturer
- FUJIFILM Healthcare Americas Corporation
- Affected units
- 77
Distribution
Distributed nationwide across the United States.
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