Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Artis zee/ zeego systems; Product Usage: Usage: Artis zee/ zeego systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. .

FDA Recall Z-1846-2015 · Posted 2015-06-25

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeOWB
Date Initiated2015-05-22
Date Terminated2016-12-13
Product Quantity475

Reason for Recall

There exists a possible position sensor fault in the swivel base axis not being detected by the system software. When moving, the system could potentially exceed its usual speed, resulting in a collision. No injuries reported.

Firm Action

Siemens sent an Important Customer Safety Notice letter dated May 22, 2015, to affected customers. The letter identified the affected product, problem and actions to be taken. The letter also informed customers that Siemens would contact them to schedule the installation of a software update to resolve the problem.

Root Cause

Software design

Distribution Pattern

US Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑