Angiodynamics, Inc.: Medical Device Recall in 2021 - (Recall #: Z-2436-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Solero Generator Refurbished US PG, Item No. H78712740000USD0, Catalog No. 12740000USD

Product Classification:

Class II

Date Initiated: July 20, 2021

Date Posted: September 15, 2021

Recall Number: Z-2436-2021

Event ID: 88444

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.

Status: Terminated

Product Quantity: 16 US, 2 OUS

Code Information:

Serial Nos. QBY0002546 QBY0002517 QBY0002525 QBY0002562 QBY0002669 QBY0002569 QBY0002382 QBY0002682 QBY0002561 QBY0002567 QBY0002580 QBY0002398 QBY0002379 QBY0002612 QBY0002708 QBY0002527 QBY0002758 QBY0002552

Distribution Pattern:

Domestic distribution Nationwide. Foreign distribution worldwide.

Voluntary or Mandated:

Voluntary: Firm initiated