Philips HeartStart MRx Monitor/Defibrillator with CO2/EtCO2 Measurement The HeartStart MRx is for use for the terminatio
FDA device recall Z-0570-2014 · posted 2013-12-24 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems, Inc.
- Reason for recall
- MRx defibrillator displays a -?- for EtCO2 and does not display EtCO2 values when patient CO2 level falls below 7.6 mmHg
- Action taken
- Philips Healthcare issued an Customer Information letter dated February 20, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer with the addendum to the Instructions for Use. If you have a ? in the parameter block and no CO2 waveform on the display, the waveform source is invalid. If invalid, check patient, confirm airway status and examine the FilterLine to make sure it is connected to the device and not kinked or pinched. For more information on the EtCO2 Option see Monitoring Carbon Dioxide chapter in the HeartStart MRx Instructions for Use. Should you have any questions or concerns, please contact your local Philips representative at 1-800-722-9377.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 18,529 units
- Distribution
- US Nationwide and OUS.
- Date initiated
- 2013-12-10
- Date posted
- 2013-12-24
- Date terminated
- 2017-04-18
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536A (K051134) | Philips Medical Systems | 2005-09-08 |