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Recall Observatory FDA recall evidence

Device product

Solero Generator Refurbished PG, Item No. H78712740000D0, Catalog No. 12740000D

Z-2438-2021

July 20, 2021

Class II

Product summary

Firm
Angiodynamics, Inc.
Event
Event 88444
Status
Terminated
Classification
Class II
Quantity
8 OUS
Official record key
device-enforcement:Z-2438-2021

Official wording

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 occur during system start-up.

Code information: Serial Nos. QBY0002816 QBY0002817 QBY0002348 QBY0002308 QBY0002311 QBY0002711 QBY0002741 QBY0002858

Distribution pattern: Domestic distribution Nationwide. Foreign distribution worldwide.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software to help reduce the incidence of Error