Apollo; Models: 9784000131 9784000231 9784020131 9784020231 9784100231 9784120131 9784120231 9784130131 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures.
FDA Recall Z-1428-2017 · Posted None
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Recalling FirmVilla Sistemi Medicali S.P.A.
Recall StatusTerminated
Product CodeKXJ
Date Initiated2016-12-27
Date Terminated2021-03-09
Product Quantity65 devices in total
Reason for Recall
Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving from vertical position.
Firm Action
Customers were notified of the recall via DHL or similar mail service. The letter identified the affected product, problem and actions to be taken.
Root Cause
Nonconforming Material/Component
Distribution Pattern
US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DC, FL, IA, IL, IN, LA, MA, MD, MI, MN, MO, MS, NJ, NY, PA, Puerto Rico, TN, TX, UT, and W.I
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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