Recall events
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Event 92455
Event summary
Timeline bucket May 19, 2023
Product types Device
Classifications Class I
Statuses Ongoing
Recalling firm wording GE Healthcare Finland Oy
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
TruSignal Adult/Pediatric Sensor; Oximeter, Ear: a) REF TS-AP-10, 10 pcs; b) REF TS-AP-25, 25 pcs
Z-2026-2023
Recall number Z-2026-2023
Initiated May 19, 2023
Classification Class I
Status Ongoing
Quantity 23537 devices
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
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-2026-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[4987]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
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Reason for recall There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
Code information a) REF TS-AP-10, GTIN 00840682103220 b) REF TS-AP-25, GTIN 00840682103220
Distribution pattern Worldwide
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[33505]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 9
TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; Oximeter
Z-2027-2023
Recall number Z-2027-2023
Initiated May 19, 2023
Classification Class I
Status Ongoing
Quantity 36337 devices
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
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-2027-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[51918]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
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Inspect official wording and provenance
Reason for recall There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
Code information a) REF TS-AF-10, GTIN 0840682103176 b) REF TS-AF-25, GTIN 0840682103176
Distribution pattern Worldwide
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[36840]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 9
TruSignal Sensitive Skin Sensor, REF TS-SE-3; Oximeter
Z-2028-2023
Recall number Z-2028-2023
Initiated May 19, 2023
Classification Class I
Status Ongoing
Quantity 2097 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
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-2028-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[46292]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
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Reason for recall There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
Code information GTIN 00840682103282
Distribution pattern Worldwide
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[35894]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 9
TruSignal Wrap Sensor, REF TS-W-D; Oximeter
Z-2029-2023
Recall number Z-2029-2023
Initiated May 19, 2023
Classification Class I
Status Ongoing
Quantity 5039 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
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-2029-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[28195]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
Code information GTIN 00840682103121
Distribution pattern Worldwide
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[35930]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 9
TruSignal Ear Sensor, REF TS-E-D; Oximeter
Z-2030-2023
Recall number Z-2030-2023
Initiated May 19, 2023
Classification Class I
Status Ongoing
Quantity 10451 devices
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
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-2030-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[4981]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
Code information GTIN 00840682103251
Distribution pattern Worldwide
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[35342]
FDA event record
· Exact recall-number query on openFDA
device · product 6 of 9
TruSignal Integrated Ear Sensor with GE Connector REF TS-E2-GE; Oximeter, Ear
Z-2031-2023
Recall number Z-2031-2023
Initiated May 19, 2023
Classification Class I
Status Ongoing
Quantity 512 devices
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
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-2031-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[21936]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
Code information GTIN 00840682103138
Distribution pattern Worldwide
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[35338]
FDA event record
· Exact recall-number query on openFDA
device · product 7 of 9
TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, physiological, patient(with arrhythmia detection or alarms)
Z-2032-2023
Recall number Z-2032-2023
Initiated May 19, 2023
Classification Class I
Status Ongoing
Quantity 2707 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
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-2032-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[46287]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
Code information GTIN 00840682103428
Distribution pattern Worldwide
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[36606]
FDA event record
· Exact recall-number query on openFDA
device · product 8 of 9
TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-N; Oximeter
Z-2033-2023
Recall number Z-2033-2023
Initiated May 19, 2023
Classification Class I
Status Ongoing
Quantity 708 devices
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
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-2033-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[9677]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
Code information GTIN 00840682103381
Distribution pattern Worldwide
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[36614]
FDA event record
· Exact recall-number query on openFDA
device · product 9 of 9
TruSignal Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H; Oximeter
Z-2034-2023
Recall number Z-2034-2023
Initiated May 19, 2023
Classification Class I
Status Ongoing
Quantity 237 devices
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
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-2034-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[16741]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
Code information GTIN 00840682103367
Distribution pattern Worldwide
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[36842]
FDA event record
· Exact recall-number query on openFDA
