Device recall: TruSignal Adult/Pediatric Sensor; Oximeter, Ear: a) REF TS-AP-10, 10 pcs; b) REF TS-AP-25, 25 pcs
Class I FDA enforcement event 92455. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
Class I, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
GE Healthcare Finland Oy started this device recall on 19 May 2023. The firm address in the FDA record is in Helsinki. FDA put the recall in Class I. FDA event 92455 has 9 product records. The first FDA enforcement report date is 12 Jul 2023. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide
Recalling firm
GE Healthcare Finland Oy, Helsinki, N/A, Finland.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
9 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2026-2023 | TruSignal Adult/Pediatric Sensor; Oximeter, Ear: a) REF TS-AP-10, 10 pcs; b) REF TS-AP-25, 25 pcs | 23537 devices | Class I | Ongoing | 12 Jul 2023 |
| Z-2027-2023 | TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; Oximeter | 36337 devices | Class I | Ongoing | 12 Jul 2023 |
| Z-2028-2023 | TruSignal Sensitive Skin Sensor, REF TS-SE-3; Oximeter | 2097 units | Class I | Ongoing | 12 Jul 2023 |
| Z-2029-2023 | TruSignal Wrap Sensor, REF TS-W-D; Oximeter | 5039 units | Class I | Ongoing | 12 Jul 2023 |
| Z-2030-2023 | TruSignal Ear Sensor, REF TS-E-D; Oximeter | 10451 devices | Class I | Ongoing | 12 Jul 2023 |
| Z-2031-2023 | TruSignal Integrated Ear Sensor with GE Connector REF TS-E2-GE; Oximeter, Ear | 512 devices | Class I | Ongoing | 12 Jul 2023 |
| Z-2032-2023 | TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, physiological, patient(with arrhythmia detection or alarms) | 2707 units | Class I | Ongoing | 12 Jul 2023 |
| Z-2033-2023 | TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-N; Oximeter | 708 devices | Class I | Ongoing | 12 Jul 2023 |
| Z-2034-2023 | TruSignal Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H; Oximeter | 237 devices | Class I | Ongoing | 12 Jul 2023 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Device events that started in 2023
- 917
- Share of these events in Class I
- 10%
- Product records in this event
- 9Median of the firm: 5
- Events of the firm on the register
- 5
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 26 Sep 2025 | Carescape B450, Model no. 5805686 - shipped with potentially affected batteries or affected batteries installed as a spa | Device | Class II | 5 |
| 5 Apr 2024 | CARESCAPE Canvas 1000, Model Numbers: a) 5865770; b) 5865770-01040169; c) 5865770-01054142; d) 5865770-01054696; e) 5865 | Device | Class II | 5 |
| 4 Sep 2018 | GE Healthcare CARESCAPE Monitor B450 Product Usage: Intended uses of CARESCAPE B450 in 510(k) countries [UR_CRSCP-885]: | Device | Class II | 2 |
| 25 May 2018 | GE Healthcare CARESCAPE Monitor B650 | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-2026-2023The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 92455. https://recallregister.com/fda/i/92455/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide
- What quantity of product is in FDA event 92455?
- The event has 9 product records. The first record gives this quantity:
23537 devices
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2023 have the same class?
- 10% of the 917 device events that started in 2023 are in Class I.