The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-0924-2015·Announced 2015-01-14

Trumpf Medical Systems Recalls JUPITER Remote Controls Due to Unintended Movement

Trumpf Medical Systems is recalling JUPITER remote controls used with operating tables because complaints were reported of unintended movement during surgical cases.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural/mechanical defect in a medical device used during surgery that resulted in reported unintended movement, meeting the criteria for a Severe rating due to the risk of significant injury.

Plain-English summary

Trumpf Medical Systems, Inc. is recalling the (R)IR remote control JUPITER, Material no. 1219656, with serial numbers up to and including 102317869. The recall involves 3,303 total devices. These remote controls are used for patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia, as well as for patient transport on the operating tabletop.

The recall was initiated due to complaints of unintended movement occurring during surgical cases caused by the use of damaged JUPITER remotes. The affected remote controls are used with various operating table columns and tables, including the Mobile column JUPITER System U, Mobile column JUPITER System Miyabi U, and Operating table column JUPITER SM 360 U.

The devices were distributed worldwide, including in the United States (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. Healthcare facilities should stop using the affected remote controls and contact the manufacturer for instructions on corrective action.

The recalled product

Product
(R)IR remote control JUPITER, Material no.1219656, Serial number: to (incl.) 102317869. 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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