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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90980

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 29, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Canon Medical System, USA, 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

1 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 1

Canon Aplio ultrasound system, Model: Aplio i900 TUS-AI900, Aplio i800 TUS-AI800, Aplio i700 TUS-AI700, Aplio a550 CUS-AA550, Aplio a450 CUS-AA450

Z-0198-2023
Recall number
Z-0198-2023
Initiated
September 29, 2022
Classification
Class II
Status
Ongoing
Quantity
65

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
After completion, ultrasound system's Stress Echo may not terminate if user does not manually terminate the protocol. During next patient exam, an abnormal confirmation message will be displayed "Same view was saved in this phase. Do you use this image with StressEcho Review?" If "no", acquired images not saved, and if "yes" images assigned to the previous patient; could cause treatment delay.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Design Change

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Inspect official wording and provenance

Reason for recall

After completion, ultrasound system's Stress Echo may not terminate if user does not manually terminate the protocol. During next patient exam, an abnormal confirmation message will be displayed "Same view was saved in this phase. Do you use this image with StressEcho Review?" If "no", acquired images not saved, and if "yes" images assigned to the previous patient; could cause treatment delay.

Code information

Model/UDI-DI, with software: Aplio i900 TUS-AI900/ 04987670102523, Aplio i800 TUS-AI800/ 04987670102516, Aplio i700 TUS-AI700/ 04987670102509, With System Version:V4.6/V5.0/V5.1, SP0005 to SP1014, or V6.0/V6.5 SP0000 to SP1009; Aplio a550 CUS-AA550/ 04987670103353, Aplio a450 CUS-AA450/ 04987670103346, With System Version: V3.0, SP0005 to SP1014, or V4.0/V4.5, SP0000 to SP1009

Distribution pattern

US: MT, MO, NC, SC, MN, WA, KY, TN, AR, IL, IA, MI, WV, KS, CA, HA, CO, LA, OK, ME, KY, NY, PA, GA, FL