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Recall Observatory FDA recall evidence

Device product

Philips Medical Systems Allura Xper FD20C with software version R8.2.O System Code: 722035. The Allura Xper FD series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures.

Z-0182-2015

July 08, 2014

Class II

Product summary

Firm
Philips Medical Systems, Inc.
Event
Event 68723
Status
Terminated
Classification
Class II
Quantity
2 units
Official record key
device-enforcement:Z-0182-2015

Official wording

Reason: Faulty Automatic Motion Controller (AMC), a problem in the Power On Self Test (POST) error handling was detected, can result in a hazardous movement of the C-arc. system.

Code information: Allura Xper Software version R8.2.0

Distribution pattern: Distributed in the states of IL, and TN, and the countries of Argentina , Australia, Belgium, Denmark, Egypt, France, Germany, Hong Kong, Italy, Japan, Korea, Republic of Netherlands, Norway, Saudi Arabia, Switzerland, United Kingdom, and Viet Nam.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Faulty Automatic Motion Controller (AMC), a problem in the Power On Self Test (POST) error handling was detected, can result in a hazardous movement of the C-arc. system.