The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0929-2015·Announced 2015-01-14

Trumpf Medical Systems Recalls JUPITER Remote Controls for Unintended Movement

Trumpf Medical Systems is recalling JUPITER remote controls due to reports of unintended movement during surgical cases caused by damaged units.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a risk of unintended movement during surgery, which poses a risk of harm to patients, but the source text does not explicitly report injuries or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Trumpf Medical Systems, Inc. is recalling 3,303 JUPITER remote controls (Material no. 1239824, Serial numbers up to and including 100139854). These devices are used for patient positioning and transport on operating tabletops during surgical procedures, ranging from anesthesia induction to recovery.

The recall is being conducted because complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes. The affected remote controls are used with various JUPITER operating table columns and systems, including the Mobile column JUPITER System U, JUPITER SM 360 U, and JUPITER UNIVERSAL U.

The affected devices were distributed worldwide, including in the United States (specifically 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, and WI) and in Canada. Users should stop using the affected remote controls and contact the manufacturer for further instructions.

The recalled product

Product
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…
Manufacturer
Trumpf Medical Systems, Inc.
Category
Medical Device — Surgical Equipment
Hazard
Affected units
3,303

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (17)

  • 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.

Distribution

Distributed in 25 states:

Part of a larger recall action

This product is one of 12 recalled by Trumpf Medical Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 12 products in this recall →

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