FDA-Device2015-12-09Class II
Patient Support Material Number: 9890 010 87431 used with: BuckyDiagnost ; Model: 704060/706037
Philips Medical Systems, Inc.
Hazard
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.
Sold states
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.
Affected count
1517 systems, not all units have the patient support accessory
Manufactured in
3000 Minuteman Rd, Andover, MA, United States
Products
Patient Support Material Number: 9890 010 87431 used with: BuckyDiagnost ; Model: 704060/706037
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0364-2016Don't want to check this manually?
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