Recall Z-0043-2017 ยท JEA Table, Surgical With Orthopedic Accessories, Ac-Powered
Trumpf Medical Systems, Inc.
Operating Table TruSystem 7000 U, Material Number 1604788; Operating Table TruSystgem 7000 U (MB), Material Number 1604786 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfe
| Date | Oct 5, 2016 (initiated Jul 10, 2016) |
| Status | Terminated |
| Reason | Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters. |
| Root cause | Nonconforming Material/Component |
| Action | Trumpf Medical sent an Urgent Field Safety Notice dated July 8, 2015, to all affected consignees. The letter indicated that the tables should not be used until an authorized service engineer has exchanged the spindles of the affected operating tables. The letter included an acknowledgement form which is to be returned. The letter also requested a sub-recall if the product had been further distributed. For questions regarding this recall call 843-329-0543. |
| Quantity | 84 units |
| Distribution | Worldwide Distribution - US including CA, CT, GA, IL, NC, OR, SC, VA, WI, WY, and Internationally to Australia, Azerbaijan, Brazil, Finland, France, Germany, Hungary, Italy, Luxembourg, Norway, Poland, Russia, Slovakia, and Switzerland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.