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

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

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