Angiodynamics, Inc.: Medical Device Recall in 2021 - (Recall #: Z-2437-2021)

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 US PG, Item No. H78712740000US0, Catalog No. 12740000US

Product Classification:

Class II

Date Initiated: July 20, 2021

Date Posted: September 15, 2021

Recall Number: Z-2437-2021

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: 26 US, 4 OUS

Code Information:

Serial Nos. QBY0002693 QBY0002376 QBY0002765 QBY0002380 QBY0002763 QBY0002662 QBY0002570 QBY0002683 QBY0002551 QBY0002618 QBY0002006 QBY0002293 QBY0002578 QBY0002666 QBY0002378 QBY0002375 QBY0002283 QBY0002539 QBY0002762 QBY0002681 QBY0002690 QBY0002389 QBY0002518 QBY0002670 QBY0002395 QBY0002687 QBY0002613 QBY0002664 QBY0002759 QBY0002780

Distribution Pattern:

Domestic distribution Nationwide. Foreign distribution worldwide.

Voluntary or Mandated:

Voluntary: Firm initiated