CLASS II Device recall · Reported 15 Sep 2021 · FDA Enforcement Report

Solero Generator Refurbished PG recalled by Angiodynamics

Angiodynamics is recalling Solero Generator Refurbished PG, distributed nationwide in the US. The recall was initiated on 20 Jul 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Nos. QBY0002816 QBY0002817 QBY0002348 QBY0002308 QBY0002311 QBY0002711 QBY0002741 QBY0002858

Quantity recalled8 OUS

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2438-2021
FDA event ID: 88444
Recalling firm: Angiodynamics, Queensbury, NY
Classification: Class II
Status: Terminated
Recall initiated: 20 Jul 2021
FDA classified: 8 Sep 2021
Reported: 15 Sep 2021
Type: Voluntary: Firm initiated
Customers notified by: N/A
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

20 Jul 2021	Recall initiated by company
8 Sep 2021	Classified by FDA	+50 days
15 Sep 2021	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

Domestic distribution Nationwide. Foreign distribution worldwide.

Nationwide

Questions about this recall

Is Solero Generator Refurbished PG recalled?

Yes. Angiodynamics recalled Solero Generator Refurbished PG on 20 Jul 2021. The recall is Class II and its status is Terminated. Recall number Z-2438-2021.

Why was it recalled?

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.

Which lots are affected?

Serial Nos. QBY0002816 QBY0002817 QBY0002348 QBY0002308 QBY0002311 QBY0002711 QBY0002741 QBY0002858

Where was it sold?

Domestic distribution Nationwide. Foreign distribution worldwide.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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