Recall events
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Event 88521
Event summary
Timeline bucket August 02, 2021
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
2 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 2
uMI 550 System - Product Usage: 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-2593-2021
Recall number Z-2593-2021
Initiated August 02, 2021
Classification Class II
Status Ongoing
Quantity 23 systems
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Device Design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2593-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[58334]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.
Code information Model: 88000057 GTIN/UDI Codes: 06971576832026 / 01 06971576832026 240 88000057 21 200017 06971576832026 / 01 06971576832026 240 88000057 21 200023 06971576832026 / 01 06971576832026 240 88000057 21 200024 06971576832026 / 01 06971576832026 240 88000057 21 200036 06971576832026 / 01 06971576832026 240 88000057 21 200045 06971576832026 / 01 06971576832026 240 88000057 21 200047 06971576832057 / 01 06971576832057 240 88000057 21 230002 06971576832057 / 01 06971576832057 240 88000057 21 230003 06971576832057 / 01 06971576832057 240 88000057 21 230004 06971576832057 / 01 06971576832057 240 88000057 21 200059 06971576832057 / 01 06971576832057 240 88000057 21 230005 06971576832057 / 01 06971576832057 240 88000057 21 230006 06971576832057 / 01 06971576832057 240 88000057 21 230007 06971576832057 / 01 06971576832057 240 88000057 21 230008 06971576832057 / 01 06971576832057 240 88000057 21 230009 06971576832057 / 01 06971576832057 240 88000057 21 230010 06971576832057 / 01 06971576832057 240 88000057 21 230011 06971576832057 / 01 06971576832057 240 88000057 21 230012 06971576832057 / 01 06971576832057 240 88000057 21 230013 06971576832057 / 01 06971576832057 240 88000057 21 230014 06971576832057 / 01 06971576832057 240 88000057 21 230015 06971576832057 / 01 06971576832057 240 88000057 21 230016 06971576832057 / 01 06971576832057 240 88000057 21 230017 Serial Numbers: 200017; 200023; 200024; 200036; 200045; 200047; 230002; 230003; 230004; 200059; 230005; 230006; 230007; 230008; 230009; 230010; 230011; 230012; 230013; 230014; 230015; 230016; 230017;
Distribution pattern U.S. Nationwide distribution in the states of CA, IL, IN, TX, and WI.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[34596]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 2
uEXPLORER PET/CT System - Product Usage: 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-2594-2021
Recall number Z-2594-2021
Initiated August 02, 2021
Classification Class II
Status Ongoing
Quantity 1 system
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Device Design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2594-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45248]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.
Code information Model: 88000025 GTIN/UDI Code: 06971576832040 / 01 06971576832040 240 88000025 21 F00002 Serial Numbers: F00002
Distribution pattern U.S. Nationwide distribution in the states of CA, IL, IN, TX, and WI.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[32841]
FDA event record
· Exact recall-number query on openFDA
