Recall Z-0391-2017 ยท JEA Table, Surgical With Orthopedic Accessories, Ac-Powered
Trumpf Medical Systems, Inc.
OR Table, Top U26 H V, Model # 1909793; OR Table Top U26 H V U, Model # 1909794; OR Table Top U24 H V, Model # 1909796; OR Table Top U24 H V U, Model # 1909797; OR Table Top U24 H V W, Model # 1909798; OR Table Top U14 H V, Model # 1909799 Product Usage: Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Patient transport on the
| Date | Nov 10, 2016 (initiated Oct 25, 2016) |
| Status | Terminated |
| Reason | Trumpf has identified six incidents of pinched cables. |
| Root cause | Process control |
| Action | Trumpf Medical sent an Urgent Medical Device Correction letter dated October 7, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken The letter indicated that a authorized service provider will inspect the table tops and make necessary corrections. A confirmation notice was included with the letter which is to be returned. For contact Trupmpf Medical Systems, Inc. at 888-474-9359. |
| Quantity | 4 (US) & 229 (Foreign) |
| Distribution | Worldwide Distribution - US Nationwide in the states of AZ and SC and the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Iceland, Italy, Norway, Qatar, Slovenia, Spain, Sweden, Switzerland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.