Z-1429-2017 Class II Terminated
FDA device recall Z-1429-2017 was initiated by Villa Sistemi Medicali S.P.A. on December 27, 2016 and is designated Class II. 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. The recall status is terminated (terminated March 9, 2021). Affected quantity: 65 devices in total.
Recall Details
- Product Type
- Devices
- Report Date
- March 15, 2017
- Initiation Date
- December 27, 2016
- Termination Date
- March 9, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 65 devices in total
Product Description
Apollo DRF; Model: 9784220831 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
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.
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
Code Information
08090531 09090591 10040680 15051450 11020798