Solero Generator Refurbished US PG, Item No. H78712740000USD0, Catalog No. 12740000USD
Summary
The FDA issued a Class II for Solero Generator Refurbished US PG, Item No. H78712740000USD0, Catalog No. 12740 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-2436-2021
Action Date
2021-09-15
Status
Terminated
Category
device
Product Description
Solero Generator Refurbished US PG, Item No. H78712740000USD0, Catalog No. 12740000USD
Lot/Code Info: Serial Nos. QBY0002546 QBY0002517 QBY0002525 QBY0002562 QBY0002669 QBY0002569 QBY0002382 QBY0002682 QBY0002561 QBY0002567 QBY0002580 QBY0002398 QBY0002379 QBY0002612 QBY0002708 QBY0002527 QBY0002758 QBY0002552
Quantity Affected: 16 US, 2 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-2436-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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