ClearanceBrief
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

DateNov 10, 2016 (initiated Oct 25, 2016)
StatusTerminated
ReasonTrumpf has identified six incidents of pinched cables.
Root causeProcess control
ActionTrumpf 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.
Quantity4 (US) & 229 (Foreign)
DistributionWorldwide 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 recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.