Trumpf Medical Systems Recalls Floor Mounting Columns for Unexpected Descent
Trumpf Medical Systems is recalling 84 Floor Mounting Columns because they unexpectedly descended approximately 20 centimeters, posing a risk to patient safety during surgery.
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 medical device with a mechanical defect that poses a risk of harm to patients, but the source text does not report any injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Trumpf Medical Systems, Inc. is recalling 84 units of the Floor Mounting Column TS 7500 U (Material Number 1730732) and Floor Mounting Column ARTIS (Material Number 1501878). These devices are used for patient positioning during surgery, ranging from anesthesia induction to recovery, and for patient transport on the operating table top.
The recall was initiated after three complaints were received describing the TruSystem tables unexpectedly descending approximately 20 centimeters. This unexpected movement presents a risk of harm to patients and medical staff during surgical procedures.
The affected units were distributed worldwide, including in the United States (California, Connecticut, Georgia, Illinois, North Carolina, Oregon, South Carolina, Virginia, Wisconsin, and Wyoming) and internationally to Australia, Azerbaijan, Brazil, Finland, France, Germany, Hungary, Italy, Luxembourg, Norway, Poland, Russia, Slovakia, and Switzerland. The specific serial numbers for the recalled units are 101900011, 101900018, 101904491, and 101904998. Healthcare facilities should contact Trumpf Medical Systems, Inc. for instructions on how to address the defect.
The recalled product
- Product
- Floor Mounting Column TS 7500 U, Material Number 1730732; Floor Mounting Column ARTIS, Material Number 1501878 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table…
- Manufacturer
- Trumpf Medical Systems, Inc.
- Affected units
- 84
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)
- Serial Numbers - 101900011
- 101900018
- 101904491
- 101904998
Distribution
Part of a larger recall action
This product is one of 4 recalled by Trumpf Medical Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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