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

OR table TITAN U, Surgical Table. Surgical bed with Orthopedic Accessories.

FDA Recall Z-0397-2012 · Posted 2012-01-11

Recalling FirmTrumpf Medical Systems, Inc.
Recall StatusTerminated
Product CodeFQO
Date Initiated2011-01-21
Date Terminated2012-08-13
Product Quantitysee line 1.

Reason for Recall

Product is being recalled due to unintended movement on the Titan Tables.

Firm Action

Trumpf Medical Systems sent an initial notification to customers dated January 24, 2011. A subsequent "URGENT SAFETY NOTICE-UPDATE" letter dated May 26, 2011 was sent to all affected customers. The letter described the product, problem, and actions to be taken by the customers. A Corrective Action Plan includes a software update to be installed by a Trumpf Technical Service Representative. Contact Technical Service at 888-474-9359 for questions regarding this notice.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution.

Official Source

View FDA Recall →

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

↑