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U.S. Department of Health and Human Services

Class 1 Device Recall GE Healthcare

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  Class 1 Device Recall GE Healthcare see related information
Date Initiated by Firm May 19, 2023
Date Posted July 07, 2023
Recall Status1 Open3, Classified
Recall Number Z-2032-2023
Recall Event ID 92455
510(K)Number K040831  
Product Classification Oximeter, ear - Product Code DPZ
Product TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, physiological, patient(with arrhythmia detection or alarms)
Code Information GTIN 00840682103428
Recalling Firm/
Manufacturer		 GE Healthcare Finland Oy
Kuortaneenkatu 2
Helsinki Finland
For Additional Information Contact
414 355 5000 Ext. 2436
Manufacturer Reason
for Recall		 There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
FDA Determined
Cause 2		 Device Design
Action GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice on 05/19/2023. The notice explained the safety issues associated with the us of the device and requested the actions be taken: Actions to be taken by Customer/User for Safety Issue # 1 and #2: 1. Use an alternate method for SpO2 monitoring such as TruSignal Sensors not impacted by this field action, or an alternate SpO2 device, if possible 2. If alternate methods are not possible, the affected TruSignal SpO2 Sensors can be used for monitoring if they have not been saturated with fluids 3. If defibrillation is necessary, when the affected TruSignal SpO2 Sensors are being used, please follow the instructions below: I. Remove the affected TruSignal SpO2 Sensor (see Table 1 below) from the patient II. Defibrillate the patient, per hospital protocol III. Reattach the affected TruSignal SpO2 Sensor after defibrillation is no longer needed Actions to be taken by Customer/User for Safety Issue #3: 1. Before using Adult/Pediatric SpO2 Sensors (see Table 1), confirm that the sensor does not contain additional material covering the emitter or detector. 2. If any additional material is present, discard the sensor and select another sensor.
Quantity in Commerce 2707 units
Distribution Worldwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DPZ and Original Applicant = DATEX-OHMEDA, INC.
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