Patient Support Material Number: 9890 010 87431 used with… — recall Z-0364-2016
U.S. FDA — Device Enforcement · United States · 2014-08-19 · Class II
As described by U.S. FDA — Device Enforcement: Patient Support Material Number: 9890 010 87431 used with: BuckyDiagnost ; Model: 704060/706037
🏛Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Distributed in the states of MN, KY, MA, VA, TX, NC, HI, FL, AZ, CT, and WY and the countries of Argentina, Australia, Austria, Canada, Denmark, Germany, Netherlands, Russia, Saudi Arabia, Singapore, Spain, and Switzerland.
Reported risk: The hook does not securely hold the footplate in vertical position. Therefore the footplate can fall or swing down and may hurt the operator or patient.
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