Recall Z-0759-2016— Trumpf Medical Systems, Inc.

Class II FDA medical device recall by Trumpf Medical Systems, Inc., initiated 2016-01-19, terminated 2016-05-24. FDA's recall record names no specific 510(k) clearance for this event. Product: Patient transport Shuttle with Trendelenburg quick adjustment function (Jupiter, Mars, Titan, TruSystem and Saturn operating table systems). The shuttle is intended for the following applications: 1. Transfer, transport and storage of exchangeable table tops in the Trumpf Medical TruSystem 7500, JUPITER, and SATURN SM operating table systems 2. Patient transport to an operating table top (without a column) from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system 3. Transporting the TruSystem 7500 SM, JUPITER SM or SATURN SM operating table column with table top (without a patient) within the operating theatre.. Reason: Complaints were received of the table top on the transporter (shuttle) tilting down quickly in a maximum Trendelenburg position..

Recalling firm

Trumpf Medical Systems, Inc.

Classification

Class II

Status

Terminated

Initiated

2016-01-19

Terminated

2016-05-24

Firm location

Charleston, SC, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.