Device product
Innocor Cardiopulmonary Exercise and Lung Function Testing System Non-invasive diagnostic device that measures or calculates a number of hemodynamic and metabolic parameters.
Z-2769-2016
Product summary
- Firm
- Innovision A/S
- Event
- Event 74649
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8
- Official record key
device-enforcement:Z-2769-2016
Official wording
Reason: 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.
Code information: Ref. INN00400, Serial no. 1551369, 1540362, 1540363, and 1536361.
Distribution pattern: Worldwide Distribution -- US, to Massachusetts and Washington, DC; and, the countries of Canada, Germany, and United Kingdom.
Derived failure modes
-
Unknown
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.