Trumpf Medical Systems Recalls TruSystem Mobile Operating Columns
Trumpf Medical Systems is recalling 84 TruSystem mobile operating columns because they may unexpectedly descend approximately 20 centimeters.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a structural defect in a medical device used during surgery that could cause significant injury to patients, meeting the criteria for a Severe rating.
Plain-English summary
Trumpf Medical Systems, Inc. is recalling 84 units of the Mobile Column TruSystem 7500 (Material Number 1717023) and Mobile Column TruSystem 5500 (Material Number 1607822). 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 due to three complaints describing the TruSystem tables unexpectedly descending approximately 20 centimeters. 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.
Healthcare facilities should identify affected units by checking the serial numbers listed in the official recall notice. Users should contact Trumpf Medical Systems for instructions on how to proceed with the recall.
The recalled product
- Product
- Mobile Column TruSystem 7500, Material Number 1717023; Mobile Column TruSystem 5500, Material Number 1607822 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.
- Category
- Medical Device — Operating Table
- 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 (20)
- Serial Numbers - 101281354
- 101856082
- 101858789
- 101858794
- 101861232
- 101871990
- 101871991
- 101871994
- 101871995
- 101871998
- 101872002
- 101872003
- 101875823
- 101884649
- 101884662
- 101890660
- 101890661
- 101890683
- 101895634
- 101912771
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.
See all 4 products in this recall →Related recalls
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- HighTrumpf Medical Systems Recalls TruSystem Operating Tables Due to Unexpected Descent
FDA (Devices) · 2016-10-12
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