IR remote control JUPITER / TS7500, Material no.1601927, Serial number: to (incl.) 102222333. 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.
- Company
- Trumpf Medical Systems, Inc.
- Recall Initiated
- December 3, 2014
- Posted
- January 6, 2015
- Terminated
- August 23, 2016
- Recall Number
- Z-0922-2015
- Quantity
- 3303 total all devices
- Firm Location
- Charleston, SC
Reason for Recall
Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes
Distribution
Worldwide Distribution - USA including AL, AZ, CA, CT, FL, GA, IL, KS, LA, MD, MI, MK, MS, NC, NH, NJ, NY, OH, OK, PA, RI, SC, TX, VA, WA, WI and Internationally to Canada.
Lot / Code Info
The operating tables which are operated with the affected remote controls (all serial numbers): Mobile column JUPITER System U, Material no. 4500113; Mobile column JUPITER System Miyabi U, Material no. 1574977; Operating table column JUPITER SM 360 U, Material no. 1389824; Operating table column JUPITER SF U OCE, Material no. 1622774; Stationary column JUPITER System U, Material no. 4500112; FLOOR MOUNTING COLUMN JUPITER U, Material no. 1276277; Floor mounting column JUPITER 360 U, Material no.1389826; Operating table JUPITER UNIVERSAL U, Material no. 4500170; OR-TABLE JUPITER UNIVERSAL CARBON U, Material no.1223188.
Root Cause
Component change control
Action Taken
Trumpf sent an Urgent Medical Device Correction letter on December 3, 2014, to all affected customers. Customers were instructed to complete and return the Confirmation of Receipt form with serial numbers of the affected table(s) and the serial number(s) for any remote controls they have. Replacement remotes will be sent. Customers were instructed to dispose of their recalled remotes. Customers with questions were instructed to call 888-474-9359. For questions regarding this recall call 843-534-0606.