Events

Recall of Device Recall JUPITER

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Trumpf Medical Systems, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    69927
  • Event Risk Class
    Class 2
  • Event Number
    Z-0918-2015
  • Event Initiated Date
    2014-12-03
  • Event Date Posted
    2015-01-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131975
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Table, surgical with orthopedic accessories, ac-powered - Product Code JEA
  • Reason
    Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged jupiter remotes.
  • Action
    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.

Device

Device Recall JUPITER
  • Model / Serial
    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.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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.
  • Product Description
    IR remote control JUC, BUTTON, Material no.1239824, Serial number: to (incl.) 100139854. || 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.
  • Manufacturer
    Trumpf Medical Systems, Inc.

Manufacturer

Trumpf Medical Systems, Inc.
  • Manufacturer Address
    Trumpf Medical Systems, Inc., 1046 Legrand Blvd, Charleston SC 29492-7672
  • Manufacturer Parent Company (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA