Cable remote control JUX Material, no.1307315, Serial number: to (incl.) 101287649. Patient posi...
FDA Recall #Z-0926-2015 — Class II — December 3, 2014
Product Description
Cable remote control JUX Material, no.1307315, Serial number: to (incl.) 101287649. 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
Recalling Firm
Trumpf Medical Systems, Inc. — Charleston, SC
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
3303 total all devices
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.
Code Information
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.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated