FDA recall Z-3188-2018

Product

sterEOS workstation

Reason for recall

3D projections may be incorrect when the pair of images used is a secondary capture generated from a series containing more than two images, where one of the images has been manually flipped. Projection errors may lead to errors in calculation of 3D clinical parameters when adjusting the position, size and shape of the 3D objects used. Incorrect clinical parameters can be a contributing factor in incorrect clinical decisions, or sub-optimal surgical interventions.

Distribution

US nationwide

Key facts

Status

Terminated

Initiation date

2018-08-01

Report date

2018-09-26

Termination date

2022-08-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Paris, N/A, France

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3188-2018