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Recall Observatory FDA recall evidence

Device product

Solero Generator Refurbished US PG, Item No. H78712740000USD0, Catalog No. 12740000USD

Z-2436-2021

July 20, 2021

Class II

Product summary

Firm
Angiodynamics, Inc.
Event
Event 88444
Status
Terminated
Classification
Class II
Quantity
16 US, 2 OUS
Official record key
device-enforcement:Z-2436-2021

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. QBY0002546 QBY0002517 QBY0002525 QBY0002562 QBY0002669 QBY0002569 QBY0002382 QBY0002682 QBY0002561 QBY0002567 QBY0002580 QBY0002398 QBY0002379 QBY0002612 QBY0002708 QBY0002527 QBY0002758 QBY0002552

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