Summary
The FDA issued a Class II for Solero Generator PG, Item No. H78712740000, Catalog No. 12740000 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-2439-2021
Action Date
2021-09-15
Status
Terminated
Category
device
Product Description
Solero Generator PG, Item No. H78712740000, Catalog No. 12740000
Lot/Code Info: Serial Nos. QBY0002623 QBY0002629 QBY0002857 QBY0002830 QBY0002843 QBY0002431 QBY0002715 QBY0002717 QBY0002731 QBY0002732 QBY0002744 QBY0002745 QBY0002363 QBY0002631 QBY0002834 QBY0001999 QBY0002000 QBY0002303 QBY0002353 QBY0002368 QBY0002432 QBY0002575 QBY0002653 QBY0002782 QBY0002783 QBY0002784 QBY0002004 QBY0002346 QBY0002576 QBY0002655 QBY0002680 QBY0002694 QBY0002709 QBY0002712 QBY0002791 QBY0002794 QBY0001991 QBY0001996 QBY0002036 QBY0002058 QBY0002703 QBY0002826 QBY0002833 QBY0002510 QBY0002624 QBY0002048 QBY0002012 QBY0002015 QBY0002481 QBY0002513 QBY0002531 QBY0002532 QBY0002812 QBY0002821 QBY0002738 QBY0002739 QBY0002564 QBY0002656 QBY0002657 QBY0002676 QBY0002014 QBY0002355 QBY0002563 QBY0002630 QBY0002743
Quantity Affected: 65 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-2439-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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