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Recall Observatory FDA recall evidence

Device product

Patient Support Material Number: 9890 010 87431, used with:EasyDiagnost ; Model: 706050

Z-0365-2016

August 19, 2014

Class II

Product summary

Firm
Philips Medical Systems, Inc.
Event
Event 69090
Status
Terminated
Classification
Class II
Quantity
260 units, not all units have the patient support accessory
Official record key
device-enforcement:Z-0365-2016

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.