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Recall Observatory FDA recall evidence

Device product

Easy Diagnost Eleva Universal Fluoroscopic applications

Z-0431-2014

October 30, 2013

Class II

Product summary

Firm
Philips Medical Systems, Inc.
Event
Event 66705
Status
Terminated
Classification
Class II
Quantity
19 devices
Official record key
device-enforcement:Z-0431-2014

Official wording

Reason: The delivered application software was an outdated version to the model of equipment.

Code information: 706050, 706083, 706088

Distribution pattern: Nationwide Distribution including MN, NH, DE, OR, MA, TX, OH, FL, CA, WA, and SC.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The delivered application software was an outdated version to the model of equipment.