The Recall Desk
SevereFDA (Devices)·Z-0923-2015·Announced 2015-01-14

Trumpf Medical Systems Recalls IIR Remote Controls for Operating Tables

Trumpf Medical Systems is recalling IIR remote controls for JUPITER operating tables due to reports of unintended movement during surgery.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a medical device used during surgery where unintended movement was reported, posing a significant risk of injury to patients, which aligns with the criteria for a Severe (Score 4) classification involving significant injury reports or high-risk device defects.

Plain-English summary

Trumpf Medical Systems, Inc. is recalling IIR remote controls (Material no. 4544120) used with JUPITER operating tables. The recall affects serial numbers up to and including 102006720. A total of 3,303 devices are involved in this recall.

The recall was initiated because complaints were reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes. These remote controls are used for patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery, as well as for patient transport on the operating tabletop.

The affected remote controls are compatible with various JUPITER operating table columns and systems, 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 and Canada. Healthcare facilities should stop using the affected remote controls and contact the manufacturer for instructions on replacement or repair.

The recalled product

Product
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 syste
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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