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.
- Company
- Trumpf Medical Systems, Inc.
- Recall Initiated
- January 19, 2016
- Terminated
- May 24, 2016
- Recall Number
- Z-0759-2016
- Quantity
- 1284 affected units
- Firm Location
- Charleston, SC
Reason for Recall
Complaints were received of the table top on the transporter (shuttle) tilting down quickly in a maximum Trendelenburg position.
Distribution
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 / Code Info
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.
Root Cause
Component design/selection
Action Taken
TRUMPF Medical sent an Urgent Field Safety Information letter dated January 15, 2016, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Customers were instructed to take the following actions: Actions to be taken 1. Remove the patient transport Shuttle from operation. 2. Trumpf Medical, or a designated service representative, will schedule an appointment with the customer to perform service on the impacted device to prevent the issue from occurring. Passing along this information: Please make sure that, in your organization, all users of the patient transport Shuttle as well as any other personnel who must be informed, have been made aware of this safety information. If you have provided the device to third parties, please forward them a copy of this letter, or inform the contact person listed above. Please store this information at least until this measure has been completed. If you have any questions concerning this request or the procedure as outlined, please contact Trumpf Medical Systems, Inc. at 888-474-9359 For questions regarding this recall call 843-534-0606.