Recall Z-2769-2016 ยท BZC Calculator, Pulmonary Function Data
Innovision A/S
Innocor Cardiopulmonary Exercise and Lung Function Testing System Non-invasive diagnostic device that measures or calculates a number of hemodynamic and metabolic parameters.
| Date | Sep 8, 2016 (initiated May 13, 2016) |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | Recall notifications described the issue and actions to be taken by the firm. The notice also stated that replacement costs would be carried by Innovision ApS. Acknowledgment of the notice can be made by contacting service manager Knud Pedersen at kp@innovision.dk or (+45) 65 95 91 00) to schedule the service activity and to answer any questions. |
| Quantity | 8 |
| Distribution | Worldwide Distribution -- US, to Massachusetts and Washington, DC; and, the countries of Canada, Germany, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102047 | LCI OPTION FOR INNOCOR Innovision A/S, Nov 1, 2011 |