Yes, I understand the recall is independent of the trial. But as you say a Cluster F and one that in my view must be closely related to the departure of the device division CEO.
The exit of the device division CEO is obviously due to that recall. The device division predates the anti-cancer division by years.
Here is evidence of why the recall was made.
In the red circle you see the offending certification label
CE stands for Conformité Européenne (French), which means European conformity.
CE marking is a self-declaration where a manufacturer proves compliance with EU health, safety and environmental protection legislation and confirms a product's compliance with relevant requirements.
Now I think this is a requirement since 2015... and this is necessary to sell their lasers in Europe. My guess here is that the TLT lasers predate 2015 so TLT probably did not apply for this label or ignored it all together.
As a former instrument sales man in my working life.... If I was a European representative I would have been hounding TLT to get this certification....which should have been a rubber stamp unless the regulations were different from the past...even then I doubt it would have taken more than a year to get.
this is the explanation of the labels shown in that picture above.
So....the red circled item here is information of their European rep.... the outfit who should have been badgering TLT for that CE certification... It is not an approval rating.
EC....CE.... potatoe/potahtoe.... Either the CEO told his staff to add the CE label and the EC explanation in the manual or at the very least approved it.
Either way he had no idea what he was doing and should have been fired IMHO.... Not only him but the staff member who did not have his back and warned him of the problem... Maybe the CEO was bossy and the staff did not like him so they let this slide to get rid of him.
The NEW CEO should address this problem immediately.... As I said ....this was a Cluster-F.