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Recall Observatory FDA recall evidence

Device product

Philips Multi Diagnost Eleva II

Z-1044-2015

October 14, 2013

Class II

Product summary

Firm
Philips Medical Systems, Inc.
Event
Event 69870
Status
Terminated
Classification
Class II
Quantity
238
Official record key
device-enforcement:Z-1044-2015

Official wording

Reason: The possibility of the Reference Air Kerma Rate for low dose mode will not be reduced to 50% of the value for the normal mode, but will be approximately 70-80%, leading to a higher patient dose than expected.

Code information: Product Code: 708036

Distribution pattern: Worldwide Distribution - USA ( nationwide ) to the states of : AR, AZ, CA, CO, DE, FL, GA, HI, IL, IA, KY, KS, LA, MI, MO, MS, NC, NY, OH, PA, TN, TX, VA, VT, WA, WY and WV., and the countries of Austria, Australia, Colombia, Germany, Switzerland, Turkey, Ireland, Dubia and United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The possibility of the Reference Air Kerma Rate for low dose mode will not be reduced to 50% of the value for the normal mode, but will be approximately 70-80%, leading to a higher patient dose than expected.