Trumpf Medical Systems, Inc. recalls IR remote control JUX, Material no.1307314, Serial number: to (incl.) 102338310 Patient positioning during surgery, ran…

Recall date

December 3, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0927-2015

FDA classification

Class II

Brand / firm

Trumpf Medical Systems, Inc.

Sold / distributed

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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

IR remote control JUX, Material no.1307314, Serial number: to (incl.) 102338310 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.