FDAFDA · Food and drugs·Recall number Z-0759-2016
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.
Published February 17, 2016 · Recall initiated: January 19, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Complaints were received of the table top on the transporter (shuttle) tilting down quickly in a maximum Trendelenburg position.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Trumpf Medical Systems, Inc.
- Distributor
- Worldwide Distribution - US including MA and TX; Foreign distribution to Austria, Azerbaijan, Belgium, British Virgin Islands, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Luxemburg, Morocco, Netherlands, New Caledonia, Norway, Poland, Portugal, Qatar, Romania, San Marino, Spain, Sweden and Switzerland.
- Lot
- Product: Shuttle 2.7, Material Number: 1254362, Serial Number Range: 100801175 101349420; Product: Shuttle 2.7 360, Material Number: 1459862, Serial Number Range: 100843669-101212847; Product: Shuttle 3.7, Material Number: 1254363, Serial Number Range: 100180383-101290987 and Product: Shuttle 3.7 360, Material Number: 1459863, Serial Number Range: 100787418-101334652.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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