The Recall Desk
HighFDA (Devices)·Z-2769-2016·Announced 2016-09-14

Innovision Innocor Cardiopulmonary Testing System Recalled for Electric Shock Risk

Innovision A/S is recalling eight Innocor Cardiopulmonary Exercise and Lung Function Testing Systems to replace USB cables that lack galvanic isolation, preventing potential electric shock.

What this means for you

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 addresses a risk of electric shock, which is a risk-of-harm product issue where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Innovision A/S is recalling eight Innocor Cardiopulmonary Exercise and Lung Function Testing Systems. These are non-invasive diagnostic devices that measure or calculate hemodynamic and metabolic parameters. The recall involves replacing the data transmission cable (USB-cable) that connects the Innocor device to an external computer.

The recall is necessary because the current USB cable uses grounding protection, which does not provide galvanic isolation. The replacement cable will use opto-couplers to provide galvanic isolation between the Innocor device and the external computer. This change is intended to prevent the risk of electric shock.

The affected units were distributed worldwide, including the United States (Massachusetts and Washington, DC), Canada, Germany, and the United Kingdom. The specific units are identified by Ref. INN00400 and serial numbers 1551369, 1540362, 1540363, and 1536361. Users should contact the manufacturer to arrange for the replacement of the USB cable.

The recalled product

Product
Innocor Cardiopulmonary Exercise and Lung Function Testing System Non-invasive diagnostic device that measures or calculates a number of hemodynamic and metabolic parameters.
Manufacturer
Innovision A/S
Category
Medical Device — Diagnostic Equipment
Hazard
Affected units
8

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 (5)

  • Ref. INN00400
  • Serial no. 1551369
  • 1540362
  • 1540363
  • and 1536361.

Distribution

Distributed in 2 states:

Related recalls

Same hazard · electric shock

See all →