Recall Z-0040-2017— 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: 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 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
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 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.