Recall Z-0042-2017— Trumpf Medical Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Trumpf Medical Systems, Inc., initiated 2016-07-10, terminated 2017-03-02. FDA's recall record names no specific 510(k) clearance for this event. 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 top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system.. Reason: Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters..
- Recalling firm
- Trumpf Medical Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-07-10
- Terminated
- 2017-03-02
- Firm location
- Charleston, SC, United States
Product description
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 top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system.
Reason for recall
Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters.
Data sourced from openFDA. This site is unofficial and independent of the FDA.