TITAN Operating Room Table Patient positioning during surgery, ranging from anesthesia induction to actual...
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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0141-2015 | Class II | Terminated | Voluntary: Firm initiated |
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