The Recall Desk
SevereFDA (Devices)·Z-0040-2017·Announced 2016-10-12

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.

What this means for you

Illness, injury, or structural failure has been reported. 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 top
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

Distributed in 10 states:

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 →