Villa Sistemi Medicali Recalls Apollo EZ X-Ray Table Due to Chain Failure
Villa Sistemi Medicali is recalling one Apollo EZ X-ray table because the angulation chain may fail early due to metal fatigue.
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 mechanical component failure in a medical device where injury has not yet been reported, fitting the rubric for risk-of-harm products without reported injury.
Plain-English summary
Villa Sistemi Medicali S.P.A. is recalling one unit of the Apollo EZ remote-controlled X-ray table, Model Number 9784152036, with Serial Number 13101261. The recall is being conducted by the U.S. Food and Drug Administration under recall number Z-0766-2020.
The recall is issued because testing revealed that the angulation chain may fail before its expected 10-year lifetime due to metal fatigue under severe workload conditions. An amendment to the Instructions for Use and Service Manual has been issued to prescribe the replacement of the angulation chain after 8 years of service.
The affected unit was distributed in the United States in the states of AL, AZ, CA, CO, CT, DC, FL, IA, IL, IN, LA, MA, MD, MI, MN, MO, MS, NJ, NY, OH, OK, PA, TN, TX, UT, and Puerto Rico. Users of this specific equipment should contact the manufacturer or their service provider to arrange for the necessary chain replacement.
The recalled product
- Product
- Apollo EZ, Model Number 9784152036 - Product Usage: The Apollo EZ remote-controlled table is X-ray equipment that can be used to perform general radiographic and fluoroscopic examinations. The system is a fixed position type. The movements of the table and tube support are motori
- Manufacturer
- Villa Sistemi Medicali S.P.A.
- Category
- Medical Device — X-Ray Equipment
- Hazard
- Affected units
- 1
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: 13101261
Distribution
Part of a larger recall action
This product is one of 4 recalled by Villa Sistemi Medicali S.P.A. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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