Z-1215-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- March 15, 2023
- Initiation Date
- December 12, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,369 units
Product Description
epoc Host 2 as follows: Product SMN epoc NXS Host, US 11413475 epoc NXS Host, EU 11413497 epoc NXS Host, Japan 11413498 epoc NXS Host, Canada 11413506 epoc NXS Host, ROW 11413518 epoc NXS Host, China-Korea 11413583
Reason for Recall
pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure
Distribution Pattern
Nationwide Foreign: Algeria Argentina Australia Austria Bahrain Belarus Belgium Bolivia Brazil Cambodia Canada Chile China Colombia Croatia Czech Republic Denmark Ecuador Egypt Estonia Finland France Fren.Polynesia Georgia Germany Greece Guadeloupe Hong Kong Hungary Iceland India Indonesia Iran Ireland Israel Italy Japan Jordan Kazakhstan Kenya Kuwait Laos Latvia Lithuania Luxembourg Malaysia Mali Martinique Mexico Myanmar Netherlands New Caledonia New Zealand Norway Papua Nw Guinea Peru Philippines Poland Portugal Qatar Republic Korea Reunion Romania Russian Fed. San Marino Singapore Slovakia Slovenia Solomon Islands South Africa Spain Sweden Switzerland Taiwan Thailand Tunisia Turkey U.A.E. Ukraine United Kingdom Uruguay Vietnam
Code Information
Host Software Version /Sensor Configuration: 4.10.6/41.1 Product Description Siemens Material Number (SMN) (UDI-DI) epoc NXS Host, US 11413475 00630414606095; epoc NXS Host, EU 11413497 00630414605760; epoc NXS Host, Japan 11413498 00630414605814; epoc NXS Host, Canada 11413506 00630414605821; epoc NXS Host, ROW 11413518 00630414605678; epoc NXS Host, China-Korea 11413583 00630414612447 .