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

Magnetom Espree with Swiveling OR (Operating Room) Table, Magnetic Resonance Imaging System,Siemens Medical Solutions USA, Inc., Malvern, PA

FDA Recall Z-0518-2008 · Posted 2008-02-05

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLNH
Date Initiated2007-11-05
Date Terminated2008-02-05
Product Quantity4 units

Reason for Recall

Table may experience a deadlock situation

Firm Action

The recalling firm issued a Customer Safety Advisory to affected customers per Update Instructions MR031/07/S. The letter informs customers of the potential issue and provides instructions to avoid its occurrence. The recalling firm has also released the software update to correct the issue via Update Instructions MR034/07/S. Notifications were issued on or about November 5, 2007.

Root Cause

Software design

Distribution Pattern

The products were shipped to medical facilities in TX and NY.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041112MAGNETOM ESPREE SYSTEMSiemens Medical Solutions USA, Inc. · 2004-07-21

Official Source

View FDA Recall →

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

↑