Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2769-2016 — Innocor Cardiopulmonary Exercise and Lung Function Testing System Non-invasive diagnostic device that measures or calculates a number of hemodynamic and metabolic parameters.

U.S. FDA — Device Enforcement · Denmark · 2016-05-13 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2769-2016
Date of alert: 2016-05-13
Country / jurisdiction: Denmark
Risk level: Class II
Risk type: recall
Brand: Innovision A/S
Product category: device
Product type: Devices

Reported risk: The purpose of the recall is to replace data transmission cable (USB-cable) connecting the lnnocor device with an external computer. The replacement USB cable will provide galvanic isolation of the lnnocor from the external computer via opto-couplers, as opposed to the grounding protection currently in use. The replacement is intended to prevent risk of electric shock.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-2769-2016 — Innocor Cardiopulmonary Exercise and Lung Function Testing System Non-invasive diagnostic device that measures or calculates a number of hemodynamic and metabolic parameters.

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