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Recall Observatory FDA recall evidence

Device product

Mobile Diagnostic X-Ray System with Digital Panel

Z-1706-2017

November 28, 2012

Class II

Product summary

Firm
Philips Healthcare Inc.
Event
Event 64902
Status
Terminated
Classification
Class II
Quantity
220 systems
Official record key
device-enforcement:Z-1706-2017

Official wording

Reason: When the operator moves an image to another view then the electronic marker might be placed at the wrong anatomical position in the resulting image.

Code information: *** All units ***

Distribution pattern: Nationwide (AR, AZ, CA, DE, FL, GA, IA, IL, IN, KS, MD, MI, MN, NC, NM, NY, OH, OR, PA, SC, TX, VT, WI)

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    When the operator moves an image to another view then the electronic marker might be placed at the wrong anatomical position in the resulting image.