Summit J700 X-Ray Tube Stand Recalled for Insufficient Welds
Summit Industries is recalling 32 J700 Floor Mounted Tube Stands because insufficient welds may cause breakage, leading to equipment damage or injury.
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 involves a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria for potential patient or provider injury from structural failure.
Plain-English summary
Summit Industries Inc. is recalling 32 units of the J700 Floor Mounted Tube Stand (FMTS). This medical device is intended to support and position the diagnostic x-ray tube housing assembly for medical radiographic procedures. The product consists of a vertical column with a counterbalanced carriage, a horizontal floor car, and a floor-mounted track.
The recall is being conducted because the welds on the tube stands may be insufficient. This defect could result in the tube stand breaking, which may cause damage to the X-Ray machine and/or injury to patients or healthcare providers.
The affected units were distributed in the United States, including the states of Arizona, Colorado, Illinois, Kentucky, Louisiana, Nebraska, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia, Washington, and West Virginia. The specific model numbers involved are J700-01, J700-02, J700-03, and J700-04.
The recalled product
- Product
- The J700 Floor Mounted Tube Stand (FMTS) is intended to support and position the diagnostic x-ray tube housing assembly for a medical radiographic procedure. The product consists of a vertical column (with counterbalanced vertical carriage, counterweight and pulley system)…
- Manufacturer
- Summit Industries Inc.
- Hazard
- Affected units
- 32
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 (4)
- Model Numbers: J700-01
- J700-02
- J700-03
- J700-04
Distribution
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