Philips Medical Systems, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0364-2016)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2015.
Data Source: FDA.
Product Description:
Patient Support Material Number: 9890 010 87431 used with: BuckyDiagnost ; Model: 704060/706037
Product Classification:
Class II
Date Initiated: August 19, 2014
Date Posted: December 9, 2015
Recall Number: Z-0364-2016
Event ID: 69090
Reason for Recall:
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.
Status: Terminated
Product Quantity: 1517 systems, not all units have the patient support accessory
Code Information:
All patient support for stitching are affected.
Distribution Pattern:
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.
Voluntary or Mandated:
Voluntary: Firm initiated