Known Identifiers & Locations
FEI Numbers
3006648320
Owner Operator Numbers
N/A
Locations Covered
N/A
Registered Establishments (0)
No device registration and listing records found for this entity.
510(k) Premarket Notifications (0)
No 510(k) notifications found for this entity.
FDA Recall History (2)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0007-2025 |
IntelliVue G7m Anesthesia Gas Module, Product Number 866173
Reason: The 866173 lntelliVue G7m Anesthesia Gas Modules could have a component issue that may trigger an interruption of the gas measurement. This issue concerns the G7m's sample gas pump which could stop working, producing a technical, INOP (inoperable) alarm. The pump may fail prematurely when there is friction caused by an abrasion. This recall is for an IMPORTANT PRODUCT NOTICE dated 1/18/23.
|
2023-01-18 |
Open, Classified
|
View Details
|
| Z-0035-2025 |
Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1
Reason: During extended operation of the MX40 with the PIC iX, the DHCP (Dynamic Host Configuration Protocol) lease can expire on the MX40. If the DHCP lease expires while the device is offline, upon reconnecting with the PIC iX, a new IP address will be assigned to the MX40. The PIC iX will not recognize the new IP address after reconnecting and therefore the expecting settings sync fails.
|
2023-04-19 |
Open, Classified
|
View Details
|
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