Skip to content
Recall Observatory FDA recall evidence

Device product

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.

Z-1428-2017

December 27, 2016

Class II

Product summary

Firm
Villa Sistemi Medicali S.P.A.
Event
Event 76367
Status
Terminated
Classification
Class II
Quantity
65 devices in total
Official record key
device-enforcement:Z-1428-2017

Official wording

Reason: 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.

Code information: Serial Numbers: 06100127 06110138 07010149 07020158 07020163 07020165 07030171 07040206 09010566 09090605 10100752 11100873 15041446

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.