HeartStart MRx Monitor/Defibrillator; Model(s), Catalogue, or Code Number: M3535A, M3536A, M3536J, M3536MC The HeartStar
FDA device recall Z-1090-2014 · posted 2014-02-25 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems, Inc.
- Reason for recall
- A component of the MRx Processor Board may be susceptible to damage from electrostatic discharge (ESD), which can disrupt ECG and SpO2 functionality leading to an inability to perform.
- Action taken
- The firm, Philips, sent an "URGENT - Medical Device Correction" letter dated February, 2014 with an attached Field Safety Notice to each known affected customer on 2/18/14. The letter describes the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. The customers were instructed to continue to use your MRx prior to receiving the hardware upgrade; if a failure has been detected that may disable some ECG and SpO2 functionality during patient care, treat your patient per existing protocols and if the condition persists, take the device out of use and call for service from Philips authorized service personnel. Philips is initiating a correction to affected devices. A hardware upgrade will be provided free of charge for all units affected by this issue. A Philips Healthcare representative will contact customers with affected devices to arrange for installation of the hardware upgrade. If you have questions regarding this notification or need any further information or support, please contact your local Philips representative or call us at 1-800-722-9377.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 39,128
- Distribution
- Worldwide Distribution: US (Nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV,
- Date initiated
- 2014-02-18
- Date posted
- 2014-02-25
- Date terminated
- 2017-01-20
- 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 |