medical Class II Updated 2020-04-29

Synaptive Medical Inc recalls Synaptive ImageDrive Clinical

Recalled Product

Synaptive ImageDrive Clinical


Hazard / Issue

A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.

Issued by

FDA

Distribution: US
Lot/Code Info: ImageDrive Clinical with part number SYN-0578- all versions of the software. With unique device identifier (UDI) #(01) 00670082000139 (10)13x1
View official government recall

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