Recall events
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Event 97668
Event summary
Timeline bucket September 12, 2025
Product types Device
Classifications Class II
Statuses Ongoing
Recalling firm wording UIH Technologies LLC
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
9 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 9
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 530 MD, Rx Only
Z-0217-2026
Recall number Z-0217-2026
Initiated September 12, 2025
Classification Class II
Status Ongoing
Quantity 8 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Other
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0217-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[46742]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Code information Serial Numbers: ; UDI: (01)06971576831012/ Serial Numbers: 300162 300163 300174 300176 304002 304003 304004 304006
Distribution pattern US: OUS:
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[1926]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 9
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 550 MD, Rx Only
Z-0218-2026
Recall number Z-0218-2026
Initiated September 12, 2025
Classification Class II
Status Ongoing
Quantity 22 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Other
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0218-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[52673]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Code information UDI:(01)06971576831036/ Serial Numbers: 353020 353021 353023 353045 353049 354001 354002 354003 354004 354005 354006 354007 354008 354009 354010 354011 354012 354013 354014 354015 354016 354017
Distribution pattern US: OUS:
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[38683]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 9
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 760 MD, Rx Only
Z-0219-2026
Recall number Z-0219-2026
Initiated September 12, 2025
Classification Class II
Status Ongoing
Quantity 11 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Other
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0219-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[35152]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Code information UDI: (01)06971576831043/Serial Number: 600229 600232 600271 600282 604001 604002 604003 604004 604005 604006 604008
Distribution pattern US: OUS:
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[2256]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 9
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 780 MD, Rx Only
Z-0220-2026
Recall number Z-0220-2026
Initiated September 12, 2025
Classification Class II
Status Ongoing
Quantity 2 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Other
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0220-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[11638]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Code information UDI: (01)06971576831050/Serial Numbers: 684001, 684002
Distribution pattern US: OUS:
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[2111]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 9
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT ATLAS MD, Rx Only
Z-0221-2026
Recall number Z-0221-2026
Initiated September 12, 2025
Classification Class II
Status Ongoing
Quantity 2 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Other
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0221-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[56079]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Code information UDI: (01)06971576831104/ Serial Numbers: 863001, 863002
Distribution pattern US: OUS:
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[1853]
FDA event record
· Exact recall-number query on openFDA
device · product 6 of 9
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uEXPLORER MD, Rx Only
Z-0222-2026
Recall number Z-0222-2026
Initiated September 12, 2025
Classification Class II
Status Ongoing
Quantity 2 UNITS
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Other
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0222-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[23330]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Code information UDI: (01)06971576832040; Serial Number: F00002, F00015
Distribution pattern US: OUS:
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[1911]
FDA event record
· Exact recall-number query on openFDA
device · product 7 of 9
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 550 MD, Rx Only
Z-0223-2026
Recall number Z-0223-2026
Initiated September 12, 2025
Classification Class II
Status Ongoing
Quantity 95 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Other
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0223-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[23328]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Code information UDI: (01)06971576832026/ Serial Numbers: 200017 200023 200024 200036 200045 200047 230002 230003 230004 230005 230006 230007 230008 230009 230011 230010 230012 230014 230013 200059 230015 230016 230017 230019 230020 230021 230022 230023 230024 230025 232001 200071 230026 230027 200072 230028 200074 230030 230029 200075 200076 230031 230032 230033 230034 230035 200079 200078 230037 230036 230038 230039 230040 230041 230042 230043 230044 230045 230047 230048 232002 202002 232003 232004 232005 230057 232006 232007 202004 232008 232009 202005 232010 202006 232011 202007 232012 232013 232014 230067 230068 230069 232015 232016 230070 230071 230073 202008 230072 230074 232017 202009 232018 232019 202010
Distribution pattern US: OUS:
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[2009]
FDA event record
· Exact recall-number query on openFDA
device · product 8 of 9
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 780 MD, Rx Only
Z-0224-2026
Recall number Z-0224-2026
Initiated September 12, 2025
Classification Class II
Status Ongoing
Quantity 3 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Other
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0224-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[35159]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Code information UDI: (01)06971576832033/ Serial Number: 300072, 300082, 300098
Distribution pattern US: OUS:
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[38681]
FDA event record
· Exact recall-number query on openFDA
device · product 9 of 9
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI Panorama 35 MD, Rx Only
Z-0225-2026
Recall number Z-0225-2026
Initiated September 12, 2025
Classification Class II
Status Ongoing
Quantity 4 unit
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Other
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0225-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[17429]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Code information UDI: (01)06971576832170/ Serial numbers: 11MI410003, 11MI410004, 11MI410005, 20MI410001
Distribution pattern US: OUS:
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[1882]
FDA event record
· Exact recall-number query on openFDA
