| Class 1 Device Recall GE Healthcare Finland O | |
Date Initiated by Firm | May 19, 2023 |
Date Posted | July 07, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-2026-2023 |
Recall Event ID |
92455 |
510(K)Number | K040831 |
Product Classification |
Oximeter, ear - Product Code DPZ
|
Product | TruSignal Adult/Pediatric Sensor; Oximeter, Ear:
a) REF TS-AP-10, 10 pcs;
b) REF TS-AP-25, 25 pcs |
Code Information |
a) REF TS-AP-10, GTIN 00840682103220
b) REF TS-AP-25, GTIN 00840682103220 |
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 | 23537 devices |
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
|
|
|
|