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Recall Observatory FDA recall evidence

Device product

Apollo DRF; Model: 9784220831 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures

Z-1429-2017

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-1429-2017

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: 08090531 09090591 10040680 15051450 11020798

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.