510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0141-2015Class II

TITAN Operating Room Table Patient positioning during surgery, ranging from anesthesia induction to actual...

Hill-Rom Inc. / initiated 2014-10-09 / Terminated / root cause: design

Trumpf Medical Systems, Inc. began a recall of TITAN Operating Room Table Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient... on . FDA classified it as Class II and gives the reason as "Unintended movement of the operating table during surgical cases due to the use of damaged TITAN remotes". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-0141-2015
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Hill-Rom Inc.
Product
TITAN Operating Room Table 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.
Product code
JEA Table, Surgical With Orthopedic Accessories, Ac-Powered
Reason for recall
Unintended movement of the operating table during surgical cases due to the use of damaged TITAN remotes.
Root cause tag
design
FDA root cause
Device Design
Action
TRUMPF sent an Urgent Medical Device Correction letter dated October 3, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken: Complete and return the attached Confirmation of Receipt form with serial numbers of the TITAN table(s) and the serial number(s) for any remote controls you have. We will then arrange to send replacement remotes, which have been redesigned to eliminate this mode of failure. You will then be required to dispose of your recalled remotes. If you have any questions concerning this request or the procedure as outlined, please contact TRUMPF Medical Systems, Inc. at 888-474-9359.
Quantity in commerce
184 units
Distribution
Worldwide Disttribution: US (nationwide) including the states of AL, AZ, CT, FL, GA, IA, IL, IN, KS, MD, MI, MN, MO, NC, ND, NJ, NM, NV, NY, OH, OR, PA, SC, TX, VA, WA and WY: and Internationally to Canada.
Product codes and lots
TITAN Operating Tables: 1465166, 1228073, 1397903, 4544260.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0141-2015
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0141-2015Class IITerminatedVoluntary: Firm initiated