The Recall Desk
ModerateFDA (Devices)·Z-0824-2018·Announced 2018-03-07

Trumpf Medical Systems Recalls Surgical Camera Systems Due to Emission Issues

Trumpf Medical Systems is recalling 212 surgical camera systems because their wireless receivers emit radiation above accepted limits, potentially interfering with other operating room devices.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential interference with other operating room devices, which is a functional risk rather than a direct physical injury or high-risk pathogen exposure, fitting the Moderate category for low-risk contamination or functional defects without reported harm.

Plain-English summary

Trumpf Medical Systems, Inc. is recalling 212 units of the Camera System, Television, Surgical without audio (Catalog Number 1940747). These devices are intended for the transmission and documentation of surgical interventions for archiving and teaching purposes.

The recall is due to the TruVidia Wireless Receiver emitting radiated emissions above normative accepted limits. This excess emission may interact with other devices in the operating room, causing them to not function properly. The affected devices were distributed worldwide, including to specific US states (GA, IL, IN, PA, SC, TX, UT, VA) and numerous international countries.

Healthcare facilities and users should identify affected units by checking the serial numbers listed in the official recall notice. Users should contact Trumpf Medical Systems for instructions on how to proceed with the recall.

The recalled product

Product
Camera System, Television, Surgical without audio Intended for transmission and documentation of surgical interventions for the purpose of archiving and teaching.
Affected units
212

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 (20)

  • Catalog Number 1940747
  • All serial numbers: 102584474
  • 102584475
  • 102584477
  • 102584478
  • 102805330
  • 102813656
  • 102813657
  • 102813658
  • 102813659
  • 102813660
  • 102813661
  • 102813662
  • 102860647
  • 102860652
  • 102863706
  • 102863707
  • 102867783
  • 102867784
  • 102925734

Distribution

Distributed in 8 states: