Solero Generator US PG recall: Software Issue
Solero Generator US PG, Item No. H78712740000US0, Catalog No. 12740000US
Why was Solero Generator US PG 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. 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
- Product
- Solero Generator US PG, Item No. H78712740000US0, Catalog No. 12740000US
- Recalling firm
- Angiodynamics, Inc.
- Quantity
- 26 US, 4 OUS
- Distribution
- Domestic distribution Nationwide. Foreign distribution worldwide.
- Recall date
- September 15, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)