Food, drugs, devices › Angiodynamics, Inc.
Device recall: Solero Generator Refurbished US PG, Item No. H78712740000USD0, Catalog No. 12740000USD
FDA enforcement event 88444 is a device recall by Angiodynamics, Inc. of Queensbury, NY, initiated 20 Jul 2021 and classified Class II, with 4 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 89% of the 900 device enforcement events initiated in 2021 carry the same class.
Status: Terminated, terminated 15 Mar 2023. Initiation: voluntary: firm initiated. Angiodynamics, Inc. has 24 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Angiodynamics, Inc., Queensbury, NY.
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."
Distribution
"Domestic distribution Nationwide. Foreign distribution worldwide."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2436-2021 | Solero Generator Refurbished US PG, Item No. H78712740000USD0, Catalog No. 12740000USD | 16 US, 2 OUS | Class II | Terminated | 15 Sep 2021 |
| Z-2437-2021 | Solero Generator US PG, Item No. H78712740000US0, Catalog No. 12740000US | 26 US, 4 OUS | Class II | Terminated | 15 Sep 2021 |
| Z-2438-2021 | Solero Generator Refurbished PG, Item No. H78712740000D0, Catalog No. 12740000D | 8 OUS | Class II | Terminated | 15 Sep 2021 |
| Z-2439-2021 | Solero Generator PG, Item No. H78712740000, Catalog No. 12740000 | 65 OUS | Class II | Terminated | 15 Sep 2021 |
Context
Other enforcement events for Angiodynamics, Inc.
All 24 events for Angiodynamics, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Domestic distribution Nationwide. Foreign distribution worldwide."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 15 Mar 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.