Haag-Streit USA Inc FDA Recalls

3 recalls on file across devices, 0 of them Class I and 3 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
OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4Class IINov 3, 2021Malfunction of the automatic laser beam shut-off, the OCT un	Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is s	Class IIDevices	Nov 3, 2021
OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4Class IINov 3, 2021Malfunction of the automatic laser beam shut-off, the OCT un	Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is s	Class IIDevices	Nov 3, 2021
Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope.Class IIApr 15, 2021Examination data and patient name may be mixed up when print	Examination data and patient name may be mixed up when printing or generating a pdf with the interface at Paci	Class IIDevices	Apr 15, 2021