Known Identifiers & Locations
FEI Numbers
1218950
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 (3)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0003-2010 |
HeartStart MRx (M3535A/M3536A) Defibrillator/Monitor.
The HeartStart MRx/MRxE is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
Reason: incorrect default configuration settings, insufficient
battery power as the user may not be alerted that no battery is installed or that a low battery condition exists prior to disconnecting from AC or DC power
|
2009-08-21 |
Terminated
|
View Details
|
| Z-0011-2013 |
Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A batteries
The Heart Start XL Defibrillator/Monitor is a fully featured, defibrillator intended for use by qualified medical personnel, trained in either Advanced Cardiac Life Support or in the operation of the device, in a hospital environment.
Reason: HeartStart XL Defibrillator/Monitor (M4735A) used on a patient when AC power is not in use, with a battery that may fail, the device may shut down unexpectedly without providing the user with a low battery warning message or audible tone.
|
2012-09-11 |
Terminated
|
View Details
|
| Z-0032-2012 |
MDC PACS - release R2.3 SP1 .
Phillips Healthcare
Andover, Massachusetts
A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Reason: Clinical measurements on true size printouts may be inaccurate
|
2011-09-01 |
Terminated
|
View Details
|
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