Recall events
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Event 85216
Event summary
Timeline bucket February 26, 2020
Product types Device
Classifications Class II
Statuses Terminated
Recalling firm wording Synaptive Medical 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
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
ClearCanvas RIS/PACS
Z-1758-2020
Recall number Z-1758-2020
Initiated February 26, 2020
Classification Class II
Status Terminated
Quantity 903 units
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
software defect
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1758-2020
Source locator 0001-device-recall-0001-of-0001.json.zip#results[56730]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.
Code information ClearCanvas RIS/PACS, partt number SYN-0524 with versions 3.0 and higher. Unique Device Identifier (UDI)# (01)00670082000115 (10)1x1
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[30105]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 2
Synaptive ImageDrive Clinical
Z-1759-2020
Recall number Z-1759-2020
Initiated February 26, 2020
Classification Class II
Status Terminated
Quantity 28 units
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
software defect
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1759-2020
Source locator 0001-device-recall-0001-of-0001.json.zip#results[16175]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.
Code information ImageDrive Clinical with part number SYN-0578- all versions of the software. With unique device identifier (UDI) #(01) 00670082000139 (10)13x1
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[30831]
FDA event record
· Exact recall-number query on openFDA
