Recall Z-2438-2021— Angiodynamics, Inc.

Name: FDA recall Z-2438-2021
Creator: U.S. Food and Drug Administration
Published: 2021-07-20

Class II · Terminated

Class II FDA medical device recall by Angiodynamics, Inc., initiated 2021-07-20, terminated 2023-03-15. It names one FDA 510(k) clearance: K162449. Product: Solero Generator Refurbished PG, Item No. H78712740000D0, Catalog No. 12740000D. Reason: Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur during system start-up..

Recalling firm: Angiodynamics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-07-20
Terminated: 2023-03-15
Firm location: Queensbury, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K162449 — Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm)AngioDynamics, Inc.·cleared 2017-05-05

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

Solero Generator Refurbished PG, Item No. H78712740000D0, Catalog No. 12740000D

Reason for recall

Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur during system start-up.

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