Villa Sistemi Medicali Recalls Apollo X-ray Tables Due to Chain Failure Risk
Villa Sistemi Medicali is recalling three Apollo X-ray tables 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 failure risk in a medical device where injury has not yet been reported, fitting the criteria for a risk-of-harm product without reported illness.
Plain-English summary
Villa Sistemi Medicali S.P.A. is recalling three units of the Apollo remote controlled X-ray system, including model numbers 9784100231, 9784120131, and 9784130131. The affected serial numbers are 08020473, 11100873, and 15041446. These units were distributed nationwide in the United States, including in Alabama, Arizona, California, Colorado, Connecticut, the District of Columbia, Florida, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, and Puerto Rico.
The recall is being issued to update the Instructions for Use and Service Manual to require the replacement of the angulation chain after 8 years of service. Testing revealed that the angulation chain might fail before its expected 10-year lifetime due to metal fatigue under severe workload conditions.
Healthcare facilities should check their records to determine if they possess any of the affected serial numbers. The manufacturer is issuing an amendment to the documentation to prescribe the necessary maintenance schedule changes.
The recalled product
- Product
- Apollo, Model Numbers 9784100231, 9784120131, 9784130131 - Product Usage: Apollo table is a remote controlled X-ray system suitable for radiography and fluoroscopy examinations. The system is stationary mounted. The movements of the table and the tube stand are motorized and remo
- Manufacturer
- Villa Sistemi Medicali S.P.A.
- Hazard
- Affected units
- 3
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: 08020473 11100873 15041446
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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