Recall Z-1214-2023 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Siemens Healthcare Diagnostics Inc
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)
| Date | Mar 3, 2023 (initiated Dec 12, 2022) |
| Status | Open, Classified |
| Reason | pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure |
| Root cause | Under Investigation by firm |
| Action | 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 |
| Quantity | 22,156 units |
| 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 Irel |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061597 | EPOC BLOOD ANALYSIS SYSTEM Epocal, Inc., Sep 27, 2006 |