Reported Feb 1, 2017 · Ongoing
Juno DRF; Model: 709020 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
Villa Radiology Systems LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Villa Radiology Systems LLC · 91 Willenbrock Rd Ste B1 · Oxford, CT · 06478-1036
Is this the product you have?
- Juno DRF
- Model709020 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures
- Lot codes and dates
101107701103080511030806110708451107084811070849110908641111090012020978120209821203099912041003120610141206101812061020120810401209107412101104121211861212118713031215131012631402130114031313140413211405133214071353140813591409136814091371141214001412140315021426150314401504144415091473150914781510148415101487
- Amount recalled
- 66 distributed in US
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a prohibited area not intended as a working position. 2) The directions for use (device labeling and instructions for use) did not contain an explicit exclusion of the prohibited area. 3.) The movement was activated inadvertently and continuously. and it was not released (the movement requires continuous activation). 4.) Delayed activation of the emergency stop.
This product could cause temporary or reversible health problems — stop using it.
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