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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88444

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 20, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Angiodynamics, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 4

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

Z-2436-2021
Recall number
Z-2436-2021
Initiated
July 20, 2021
Classification
Class II
Status
Terminated
Recalling firm
Angiodynamics, Inc.
Quantity
16 US, 2 OUS

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software to help reduce the incidence of Error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

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.

device · product 2 of 4

Solero Generator US PG, Item No. H78712740000US0, Catalog No. 12740000US

Z-2437-2021
Recall number
Z-2437-2021
Initiated
July 20, 2021
Classification
Class II
Status
Terminated
Recalling firm
Angiodynamics, Inc.
Quantity
26 US, 4 OUS

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software to help reduce the incidence of Error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Serial Nos. QBY0002693 QBY0002376 QBY0002765 QBY0002380 QBY0002763 QBY0002662 QBY0002570 QBY0002683 QBY0002551 QBY0002618 QBY0002006 QBY0002293 QBY0002578 QBY0002666 QBY0002378 QBY0002375 QBY0002283 QBY0002539 QBY0002762 QBY0002681 QBY0002690 QBY0002389 QBY0002518 QBY0002670 QBY0002395 QBY0002687 QBY0002613 QBY0002664 QBY0002759 QBY0002780

Distribution pattern

Domestic distribution Nationwide. Foreign distribution worldwide.

device · product 3 of 4

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

Z-2438-2021
Recall number
Z-2438-2021
Initiated
July 20, 2021
Classification
Class II
Status
Terminated
Recalling firm
Angiodynamics, Inc.
Quantity
8 OUS

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software to help reduce the incidence of Error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Serial Nos. QBY0002816 QBY0002817 QBY0002348 QBY0002308 QBY0002311 QBY0002711 QBY0002741 QBY0002858

Distribution pattern

Domestic distribution Nationwide. Foreign distribution worldwide.

device · product 4 of 4

Solero Generator PG, Item No. H78712740000, Catalog No. 12740000

Z-2439-2021
Recall number
Z-2439-2021
Initiated
July 20, 2021
Classification
Class II
Status
Terminated
Recalling firm
Angiodynamics, Inc.
Quantity
65 OUS

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software to help reduce the incidence of Error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

Domestic distribution Nationwide. Foreign distribution worldwide.