epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2, Canada 10736388 epoc Host 2, China 10736389 epoc Host 2, Japan 10736390 epoc Host 2, Refurbished 10736393 epoc Host 2, Canada, Refurbished 10736394 epoc Host 2, Japanese, Refurbished 10736395 epoc Host 2, Chinese, Refurbished 10736433 epoc Host 2, US (MC55X) 11413524 epoc Host 2, ROW (MC55X) 11413528 epoc Host 2, India (MC55X) 11413541 epoc Host 2, China (MC55X) 11413542 epoc Host 2, Japan (MC55X) 11413543 epoc Host 2 (MC55X) - US - Refurbished 11413601 "epoc Host 2 (MC55X) - ROW -Refurbished" 11413602 epoc Host 2 (MC55X) - India - Refurbished 11413603 epoc Host 2 (MC55X) - Japan - Refurbished 11413604
- Recall Initiated
- December 12, 2022
- Posted
- March 3, 2023
- Recall Number
- Z-1214-2023
- Quantity
- 22,156 units
- Firm Location
- Norwood, MA
Reason for Recall
pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure
Distribution
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
Lot / Code Info
Host Software Version /Sensor Configuration: 3.37.3/41.1 Product Description Siemens Material Number (SMN) Unique Device Identification (UDI-DI) epoc Host 2 10736387 00809708052898; epoc Host 2, Canada 10736388 00809708069117; epoc Host 2, China 10736389 00809708097219; epoc Host 2, Japan 10736390 00809708075576; epoc Host 2, Refurbished 10736393 00809708053901; epoc Host 2, Canada, Refurbished 10736394 00809708069124; epoc Host 2, Japanese, Refurbished 10736395 00809708075583; epoc Host 2, Chinese, Refurbished 10736433 00809708097226; epoc Host 2, US (MC55X) 11413524 00630414606460; epoc Host 2, ROW (MC55X) 11413528 00630414606378; epoc Host 2, India (MC55X) 11413541 00630414608617; epoc Host 2, China (MC55X) 11413542 00630414608624; epoc Host 2, Japan (MC55X) 11413543 00630414608532; epoc Host 2 (MC55X) - US - Refurbished 11413601 00630414615004; "epoc Host 2 (MC55X) - ROW - Refurbished" 11413602 00630414614885; epoc Host 2 (MC55X) - India - Refurbished 1413603 00630414614762; epoc Host 2 (MC55X) - Japan - Refurbished 11413604 00630414614892.
Root Cause
Under Investigation by firm
Action Taken
Siemens has issued an Urgent Medical Device Correction POC 23-004.A.US on December 12, 2022 and Urgent Field Safety Notice POC 23-004.A.OUS to customers informing them of the issue and providing workaround for customers to use until the affected sensor configuration/software version expires on June 12, 2023. The next sensor configuration with the fix and its corresponding sw version will be available to customers in April 2023. Letter states reason for recall, health risk and action to take: " Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. " If you are a distributor, please ensure your customers receive this UMDC letter. " If you perform QC tests at barometric pressures equal to or above 730 mmHg (97 kPa), no additional action is required. " If you perform QC tests at barometric pressures less than 730 mmHg (97 kPa), apply barometric correction factors before comparing the gas readings with the published value assignments. ***Important Note*** The above barometric correction factor should be applied only to epoc System Software sensor configuration 41.1, epoc Host 2 SW Version 3.37.3 and epoc NXS Host SW Version 4.10.6, which expires June 12, 2023. Following the expiration of this sensor configuration and the software version refer to the epoc System Manual Section 9.5.1 for the appropriate Barometric Correction factor to apply." Please review this letter with your Medical Director." Please retain this letter with your laboratory records and forward this letter to those who may have received the affected product. Questions, please contact your Siemens Healthineers Technical Solution Center or your local Siemens Healthineers technical support representative.