Recall Z-0927-2015 ยท JEA Table, Surgical With Orthopedic Accessories, Ac-Powered
Trumpf Medical Systems, Inc.
IR remote control JUX, Material no.1307314, Serial number: to (incl.) 102338310 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.
| Date | Jan 6, 2015 (initiated Dec 3, 2014) |
| Status | Terminated |
| Reason | Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes |
| Root cause | Component change control |
| Action | Trumpf sent an Urgent Medical Device Correction letter on December 3, 2014, to all affected customers. Customers were instructed to complete and return the Confirmation of Receipt form with serial numbers of the affected table(s) and the serial number(s) for any remote controls they have. Replacement remotes will be sent. Customers were instructed to dispose of their recalled remotes. Customers with questions were instructed to call 888-474-9359. For questions regarding this recall call 843-534-0606. |
| Quantity | 3303 total all devices |
| Distribution | Worldwide Distribution - USA including AL, AZ, CA, CT, FL, GA, IL, KS, LA, MD, MI, MK, MS, NC, NH, NJ, NY, OH, OK, PA, RI, SC, TX, VA, WA, WI and Internationally to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.