Device not manufactured by reporting manufacturer

Definition

Further information was obtained which established that the manufacturer of the device involved was not the one to which it was initially attributed.

Also indexed as

Nearby in Cause investigation and type of investigation

• XE9HDTesting of actual or suspected device
• XE7XHTesting of device from same lot or batch retained by manufacturer
• XE4S0Testing of device from same lot batch returned from user
• XE2ZRTesting of device from other lot batch retained by manufacturer
• XE4X1Testing of device from other lot or batch returned from user
• XE1XTTesting of model variant
• XE8XVTesting of raw or starting materials
• XE6FSTesting of patient sample or reference material using manufacturer's device