Solero Generator US PG, Item No. H78712740000US0, Catalog No. 12740000US
Summary
The FDA issued a Class II for Solero Generator US PG, Item No. H78712740000US0, Catalog No. 12740000US by Angiodynamics, Inc.. Reason: Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can oc.
Details
Source
Device Recall
External ID
Z-2437-2021
Action Date
2021-09-15
Status
Terminated
Category
device
Product Description
Solero Generator US PG, Item No. H78712740000US0, Catalog No. 12740000US
Lot/Code Info: 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
Quantity Affected: 26 US, 4 OUS
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-20
Company
Queensbury, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 147 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Angiodynamics, Inc. has 73 FDA actions in our database, including 64 recalls and 9 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Angiodynamics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Angiodynamics, Inc. have FDA actions?
Angiodynamics, Inc. has 73 FDA actions in our database, including 64 recalls and 9 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2437-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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