Recall Z-0759-2016 ยท JEA Table, Surgical With Orthopedic Accessories, Ac-Powered
Trumpf Medical Systems, Inc.
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
| Date | Jan 19, 2016 |
| Status | Terminated |
| Reason | Complaints were received of the table top on the transporter (shuttle) tilting down quickly in a maximum Trendelenburg position. |
| Root cause | Component design/selection |
| Action | 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 organizati |
| Quantity | 1284 affected units |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.