Recall Z-1759-2020— Synaptive Medical Inc

Name: FDA recall Z-1759-2020
Creator: U.S. Food and Drug Administration
Published: 2020-02-26

Class II · Terminated

Class II FDA medical device recall by Synaptive Medical Inc, initiated 2020-02-26, terminated 2024-04-10. It names one FDA 510(k) clearance: K153284. Product: Synaptive ImageDrive Clinical. Reason: A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis..

Recalling firm: Synaptive Medical Inc
Classification: Class II
Status: Terminated
Initiated: 2020-02-26
Terminated: 2024-04-10
Firm location: Toronto, N/A, Canada

510(k) clearances named in this recall

1 on FDA's record

K153284 — Synaptive ImageDrive ProSynaptive Medical, Inc.·cleared 2016-03-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Synaptive ImageDrive Clinical

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.