FDA-Device2015-01-14Class II

IIR remote control JUPITER, Material no.4544120, Serial number: to (incl.) 102006720. 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.

Trumpf Medical Systems, Inc.
Hazard

Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes

Sold states
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.
Affected count
3303 total all devices
Manufactured in
1046 Legrand Blvd, N/A, Charleston, SC, United States
Products
IIR remote control JUPITER, Material no.4544120, Serial number: to (incl.) 102006720. 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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0923-2015

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