FDA recall Z-1243-2022

Siemens Medical Solutions USA, Inc · Class II · device

Product

Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 6648153 6648161 10140973 10764561 10765502 10910620

Reason for recall

Siemens has become aware of three potential software issues with AXIOM Sensis or Sensis/ Sensis Lite systems. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and treatment needs to be continued on an alternate system.

Distribution

Domestic distribution nationwide.

Key facts

Status: Ongoing
Initiation date: 2022-04-13
Report date: 2022-06-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1243-2022