FDA recall Z-1148-2018

Siemens Medical Solutions USA, Inc · Class II · device

Product

Artis one fluoroscopic x-ray system and patient table Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Arts one include cardiac angiography, neuro-angiography, general angiography, rotational angiography; multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e. patient extremities.

Reason for recall

Certain patient table systems may have a missing or incorrectly installed snap ring that could cause the bolt to slide out of its base and the tabletop carriage to slide to the floor.

Distribution

US Distribution to the states of : AL, AR, CA, FL, IN, LA, MI, MO, NC, NY, PA, TX, and WA.

Key facts

Status
Terminated
Initiation date
2018-01-12
Report date
2018-03-28
Termination date
2018-08-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1148-2018