Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and HEMOXSC10
FDA device recall Z-0496-2018 · posted 2018-01-16 · Terminated
Recall details
- Recalling firm
- Edwards Lifesciences, LLC
- Reason for recall
- Pre-procedural issues related to software defects
- Action taken
- Consignees were sent recall notification letters on approximately 10/11/2017. The letter identified the affected product, problem and actions to be taken. instructions included coordination with the respective Edwards representative to schedule the software upgrade.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DQK
- Quantity affected
- 198 devices
- Distribution
- US Nationwide Distributed in the states of AZ, CA, CO, GA, IL, MO, NM, OK, OR, SC, TX
- Date initiated
- 2017-10-02
- Date posted
- 2018-01-16
- Date terminated
- 2020-12-14
- Location
- Irvine, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable (K163381) | Edwards Lifesciences, LLC | 2017-04-14 |