FDAFDA · Food and drugs·Recall number Z-1429-2017
Apollo DRF; Model: 9784220831 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
Published March 15, 2017 · Recall initiated: December 27, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Villa Sistemi Medicali S.P.A.
- Distributor
- 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
- Lot
- 08090531 09090591 10040680 15051450 11020798
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Italy
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