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Recall Observatory FDA recall evidence

Device product

GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 A medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems.

Z-0125-2013

May 24, 2012

Class II

Product summary

Firm
GE Healthcare, LLC
Event
Event 61612
Status
Terminated
Classification
Class II
Quantity
12
Official record key
device-enforcement:Z-0125-2013

Official wording

Reason: GE Healthcare has recently become aware of inaccurate Scale factor annotation provided by SenoAdvantage 2.2 workstations that may impact patient safety. This issue may result in a potential miscalculation of size.

Code information: 000000010005GS 000000010004GS 000000010009GS 000000010007GS 000000010006GS 000000010010GS 000000010001GS 000000010002GS 000000010008GS 000000010003GS 00000L3A4391A7 00000L3A8D5CF0

Distribution pattern: Worldwide Distribution -- USA (nationwide) including states of: CA, CT, NY, TX, and MS and countries of TAIWAN, ITALY, CANADA, and BAHRAIN

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    GE Healthcare has recently become aware of inaccurate Scale factor annotation provided by SenoAdvantage 2.2 workstations that may impact patient safety. This issue may result in a potential miscalculation of size.