Z-2438-2021 Class II Terminated
FDA device recall Z-2438-2021 was initiated by Angiodynamics, Inc. on July 20, 2021 and is designated Class II. 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. The recall status is terminated (terminated March 15, 2023). Affected quantity: 8 OUS.
Recall Details
- Product Type
- Devices
- Report Date
- September 15, 2021
- Initiation Date
- July 20, 2021
- Termination Date
- March 15, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 OUS
Product Description
Solero Generator Refurbished PG, Item No. H78712740000D0, Catalog No. 12740000D
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 Pattern
Domestic distribution Nationwide. Foreign distribution worldwide.
Code Information
Serial Nos. QBY0002816 QBY0002817 QBY0002348 QBY0002308 QBY0002311 QBY0002711 QBY0002741 QBY0002858