FDAClass IISeptember 15, 2021

Solero Generator recall: Software Issue

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

Why was Solero Generator 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Serial Nos. QBY0002816 QBY0002817 QBY0002348 QBY0002308 QBY0002311 QBY0002711 QBY0002741 QBY0002858

Product
Solero Generator Refurbished PG, Item No. H78712740000D0, Catalog No. 12740000D
Recalling firm
Angiodynamics, Inc.
Quantity
8 OUS
Distribution
Domestic distribution Nationwide. Foreign distribution worldwide.
Recall date
September 15, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
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