Arcoma AB FDA Recalls

2 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Omnera 400A Digital Radiographic SystemClass IIMay 5, 2021There is the potential for the X-Ray system to short circu	There is the potential for the X-Ray system to short circuit due to an ingress of liquid in the display han	Class IIDevices	May 5, 2021
Omnera 400T Digital Radiographic SystemClass IIMay 5, 2021There is the potential for the X-Ray system to short circu	There is the potential for the X-Ray system to short circuit due to an ingress of liquid in the display han	Class IIDevices	May 5, 2021