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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85453

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

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Event summary

Timeline bucket
March 26, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Shanghai United Imaging Healthcare Co., Ltd.

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

Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 88000057 - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.

Z-2819-2020
Recall number
Z-2819-2020
Initiated
March 26, 2020
Classification
Class II
Status
Terminated
Quantity
3

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software version, of Positron emission tomography and computed tomography system, the CT Hounsfield unit curve may

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

In affected software version, of Positron emission tomography and computed tomography system, the CT Hounsfield unit curve may not display in real time when using the bolus tracking protocol with the tracker scan function. If this occurs, the subsequent clinical scanning protocols will need to be started manually, which may effect image enhancement, and may result in patient rescan.

Code information

UDI: 06971576832026, Software Version: R001.3.0.0.750505, Serial Numbers: 200017, 200023, 200024

Distribution pattern

US Nationwide distribution including in the state of TX.