Recall events
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Event 74189
Event summary
Timeline bucket May 05, 2016
Product types Device
Classifications Class II
Statuses Terminated
Recalling firm wording Ellipse A/S
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
Ellipse ND: YAG Laser applicator for Ellipse Multiflex Medical Laser Products.
Z-1697-2016
Recall number Z-1697-2016
Initiated May 05, 2016
Classification Class II
Status Terminated
Quantity US - 14
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Failure to provide the required instructions specifying a procedure and schedule for calibration of the measurement system.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Radiation Control for Health and Safety Act
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1697-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[44231]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Failure to provide the required instructions specifying a procedure and schedule for calibration of the measurement system.
Code information All serial numbers
Distribution pattern Nationwide Distribution to the states of : NJ, PA, MI, CO, CA, FL, OK, NY, NH, CT, AZ and MO.
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[19170]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 2
Ellipse ND: YAG Laser applicator for Ellipse Nordlys system Medical Laser Products.
Z-1698-2016
Recall number Z-1698-2016
Initiated May 05, 2016
Classification Class II
Status Terminated
Quantity US - 25
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Failure to provide the required instructions specifying a procedure and schedule for calibration of the measurement system.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Radiation Control for Health and Safety Act
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1698-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[24728]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Failure to provide the required instructions specifying a procedure and schedule for calibration of the measurement system.
Code information All serial numbers
Distribution pattern Nationwide Distribution to the states of : NJ, PA, MI, CO, CA, FL, OK, NY, NH, CT, AZ and MO.
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[19318]
FDA event record
· Exact recall-number query on openFDA
