Known Identifiers & Locations
FEI Numbers
1030184
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 (4)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0011-04 |
Power cord manufactured by ElectriCord Manufacturing Company , P/N 316579, used with DINAMAP Patient Monitors as Follows: DINAMAP PRO Series, DINAMAP PRO 1000 Monitor under both the Critikon and GE Medical Systems. The company name EliectriCord is on the power cord plug.
Reason: Reports of broken plug ground pins on AC power cords for patient monitors.
|
2003-04-30 |
Terminated
|
View Details
|
| Z-0013-04 |
Critikon brand Omni-Stat Finger Sensor - P/N 009084
Reason: Instructions for use contained incorrect sensor reference.
|
2000-11-16 |
Terminated
|
View Details
|
| Z-0014-04 |
Critikon brand Omni-Sat Neonatal, Semi-Disposable Sensor, P/N 009130
Reason: Instructions for use contained incorrect sensor reference.
|
2000-11-16 |
Terminated
|
View Details
|
| Z-0015-04 |
Critikon brand Omni-Sat Adult, Semi-Disposable Sensor - P/N 009136
Reason: Instructions for use contained incorrect sensor reference.
|
2000-11-16 |
Terminated
|
View Details
|
Profile Disclaimer
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