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Terminated

Juno DRF; Model: 709020 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures

FDA Recall Z-1427-2017 · Posted None

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.

K050190APOLLOVilla Sistemi Medicali S.P.A. · 2005-03-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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