Trumpf TITAN Operating Room Table Recalled for Unintended Movement
Trumpf Medical Systems is recalling 184 TITAN Operating Room Tables due to unintended movement during surgery caused by damaged remotes.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device defect (unintended movement during surgery) where injury has not yet been reported, fitting the High severity criteria for risk-of-harm products.
Plain-English summary
Trumpf Medical Systems, Inc. is recalling 184 units of the TITAN Operating Room Table. The recall is due to unintended movement of the operating table during surgical cases, which is attributed to the use of damaged TITAN remotes.
The affected units were distributed nationwide in the United States and internationally to Canada. The specific serial numbers for the recalled units are 1465166, 1228073, 1397903, and 4544260.
Healthcare facilities should contact Trumpf Medical Systems for instructions on how to address the defect and ensure patient safety during surgical procedures.
The recalled product
- 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…
- Manufacturer
- Trumpf Medical Systems, Inc.
- Affected units
- 184
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- TITAN Operating Tables: 1465166
- 1228073
- 1397903
- 4544260.
Distribution
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