Synaptive Medical Inc: Medical Device Recall in 2020 - (Recall #: Z-1759-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Synaptive ImageDrive Clinical

Product Classification:

Class II

Date Initiated: February 26, 2020

Date Posted: April 29, 2020

Recall Number: Z-1759-2020

Event ID: 85216

Reason for Recall:

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

Status: Terminated

Product Quantity: 28 units

Code Information:

ImageDrive Clinical with part number SYN-0578- all versions of the software. With unique device identifier (UDI) #(01) 00670082000139 (10)13x1

Distribution Pattern:

Voluntary or Mandated:

Voluntary: Firm initiated