Trumpf TruSystem Surgical Table Leg Section Recall for Detachment Risk
Trumpf Medical Systems is recalling 15 TruSystem Surgical Table Leg Section One Part Light components because the coupler point may detach from the frame.
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 structural defect in a medical device used during surgery that could lead to patient injury, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Trumpf Medical Systems, Inc. is recalling 15 components of the TruSystem Surgical Table (TS7000) Leg Section One Part Light HU. The recall involves Item no. 1739993 and all serial numbers. These components are used to position patients' legs during pre-op and post-op surgery and are attached to coupling point L on the operating table.
The recall is being issued because the coupler point (hood) of the Leg Section One Part Light may become detached from the leg section frame. This defect could compromise the stability of the patient positioning system during surgical procedures.
The affected components were distributed in the United States, including the states of California, Illinois, New Jersey, New York, North Carolina, Texas, Washington, and South Carolina. Users of these surgical tables should contact Trumpf Medical Systems, Inc. for instructions on how to address the defect.
The recalled product
- Product
- TruSystem Surgical Table (TS7000) Leg Section One Part Light HU Use of the Leg Section One Part Light HU is permitted only with the TRUMPF TruSystem 7000 operating table. The operating table TruSystem 7000, in conjunction with operating table components is intended for the…
- Manufacturer
- Trumpf Medical Systems, Inc.
- Category
- Medical Device — Surgical Table
- Affected units
- 15
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 (2)
- Item no. 1739993
- All serial numbers.
Distribution
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