Innocor Cardiopulmonary Exercise and Lung Function Testing System Non-invasive diagnostic device that measures or calcul
FDA device recall Z-2769-2016 · posted 2016-09-08 · Terminated
Recall details
- Recalling firm
- Innovision A/S
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- BZC
- Quantity affected
- 8
- Distribution
- Worldwide Distribution -- US, to Massachusetts and Washington, DC; and, the countries of Canada, Germany, and United Kingdom.
- Date initiated
- 2016-05-13
- Date posted
- 2016-09-08
- Date terminated
- 2017-02-10
- Location
- Glamsbjerg, Denmark
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LCI OPTION FOR INNOCOR (K102047) | Innovision A/S | 2011-11-01 |