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Recall Observatory FDA recall evidence

Device product

Philips DigitalDiagnost 3.1.x X-Ray System

Z-2154-2017

May 11, 2017

Class II

Product summary

Firm
Philips Electronics North America Corporation
Event
Event 77312
Status
Terminated
Classification
Class II
Quantity
US - 132
Official record key
device-enforcement:Z-2154-2017

Official wording

Reason: During recent evaluations of the Philips DigitalDiagnost 3.1.x, we have identified a potential issue that may affect the performance of the equipment under certain conditions.

Code information: DigitalDiagnost Upgrade Release 3.1.x to 3.1.3

Distribution pattern: USA(nationwide) Distribution to the states of : AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KY, LA, MA, ME, MI, MN, MO, NC, ND, NE, NH, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA and WI

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    During recent evaluations of the Philips DigitalDiagnost 3.1.x, we have identified a potential issue that may affect the performance of the equipment under certain conditions.