Philips Medical Systems, Inc. recalls Patient Support Material Number: 9890 010 87431 used with: BuckyDiagnost ; Model: 704060/706037

Recall date

August 19, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0364-2016

FDA classification

Class II

Brand / firm

Philips Medical Systems, Inc.

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Patient Support Material Number: 9890 010 87431 used with: BuckyDiagnost ; Model: 704060/706037