Recall – X-ray system images may be incorrectly labeled due to software error

Company: Philips Medical Systems (Cleveland) Inc
Date of Enforcement Report: 8/14/2019
Class II

PRODUCT

Ingenuity CT, Model # 728326, computed tomography x-ray system

  • Recall Number: Z-2186-2019

Ingenuity Core128 Model # 728323, computed tomography x-ray system

  • Recall Number: Z-2187-2019

Ingenuity Core Model # 728321, computed tomography x-ray system

  • Recall Number: Z-2188-2019

iCT, Model # 728306, computed tomography x-ray system

  • Recall Number: Z-2189-2019

iCT SP Model # 728311, computed tomography x-ray system

  • Recall Number: Z-2190-2019

Brilliance 64 Model # 728231, computed tomography x-ray system

  • Recall Number: Z-2191-2019

IQon Spectral CT Model # 728332, computed tomography x-ray system

  • Recall Number: Z-2192-2019

Ingenuity TF PET/CT Model # 882456, computed tomography x-ray system

  • Recall Number: Z-2193-2019

Vereos PET/CT Model # 882446, computed tomography x-ray system

  • Recall Number: Z-2194-2019

REASON

In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied

RECALLING FIRM/MANUFACTURER

Philips Medical Systems (Cleveland) Inc on 6/24/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

92

DISTRIBUTION

US Nationwide and International

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