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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91870

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

Open FDA event record

Event summary

Timeline bucket
March 01, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
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

Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057

Z-1353-2023
Recall number
Z-1353-2023
Initiated
March 01, 2023
Classification
Class II
Status
Ongoing
Quantity
47 systems (U.S. only)

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software issue

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

Due to a software issue where the process of patient scanning, the scatter correction may occasionally fail with will potentially cause a failure of the PET image reconstruction and generation of PET images.

Code information

Models: 88000657 Serial Number/UDI Code: 230003 / 01 06971576832057 240 88000657 21 230003 230005 / 01 06971576832057 240 88000657 21 230005 230007 / 01 06971576832057 240 88000657 21 230007 230012 / 01 06971576832057 240 88000657 21 230012 230013 / 01 06971576832057 240 88000657 21 230013 230014 / 01 06971576832057 240 88000657 21 230014 230015 / 01 06971576832057 240 88000657 21 230015 230016 / 01 06971576832057 240 88000657 21 230016 230017 / 01 06971576832057 240 88000657 21 230017 230020 / 01 06971576832057 240 88000657 21 230020 230021 / 01 06971576832057 240 88000657 21 230021 230022 / 01 06971576832057 240 88000657 21 230022 230023 / 01 06971576832057 240 88000657 21 230023 230024 / 01 06971576832057 240 88000657 21 230024 230026 / 01 06971576832057 240 88000657 21 230026 230027 / 01 06971576832057 240 88000657 21 230027 230028 / 01 06971576832057 240 88000657 21 230028 230029 / 01 06971576832057 240 88000657 21 230029 230030 / 01 06971576832057 240 88000657 21 230030 230031 / 01 06971576832057 240 88000657 21 230031 230032 / 01 06971576832057 240 88000657 21 230032 230033 / 01 06971576832057 240 88000657 21 230033 230035 / 01 06971576832057 240 88000657 21 230035 230036 / 01 06971576832057 240 88000657 21 230036 230037 / 01 06971576832057 240 88000657 21 230037 230038 / 01 06971576832057 240 88000657 21 230038 230039 / 01 06971576832057 240 88000657 21 230039 230040 / 01 06971576832057 240 88000657 21 230040 230041 / 01 06971576832057 240 88000657 21 230041 230042 / 01 06971576832057 240 88000657 21 230042 230043 / 01 06971576832057 240 88000657 21 230043 230044 / 01 06971576832057 240 88000657 21 230044 230045 / 01 06971576832057 240 88000657 21 230045 230047 / 01 06971576832057 240 88000657 21 230047 230048 / 01 06971576832057 240 88000657 21 230048 Model Number: 88000057 Serial Number/UDI Code: 200017 / 01 06971576832026 240 88000057 21 200017 200023 / 01 06971576832026 240 88000057 21 200023 200024 / 01 06971576832026 240 88000057 21 200024 200036 / 01 06971576832026 240 88000057 21 200036 200045 / 01 06971576832026 240 88000057 21 200045 200047 / 01 06971576832026 240 88000057 21 200047 200059 / 01 06971576832026 240 88000057 21 200059 200071 / 01 06971576832026 240 88000057 21 200071 200072 / 01 06971576832026 240 88000057 21 200072 200075 / 01 06971576832026 240 88000057 21 200075 200078 / 01 06971576832026 240 88000057 21 200078 200079 / 01 06971576832026 240 88000057 21 200079

Distribution pattern

U.S. Nationwide distribution in the state of TX. O.U.S.: Not provided.