Recall Z-0919-2015— Trumpf Medical Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Trumpf Medical Systems, Inc., initiated 2014-12-03, terminated 2016-08-23. FDA's recall record names no specific 510(k) clearance for this event. Product: Cable remote control JUPITER / TS7500, Material no.1601926, Serial number: to (incl.) 101465919. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.. Reason: Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes.
- Recalling firm
- Trumpf Medical Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-12-03
- Terminated
- 2016-08-23
- Firm location
- Charleston, SC, United States
Product description
Cable remote control JUPITER / TS7500, Material no.1601926, Serial number: to (incl.) 101465919. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.
Reason for recall
Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes
Data sourced from openFDA. This site is unofficial and independent of the FDA.