Philips HeartStart MRx Monitor/Defibrillator used Model numbers: M3535A, M3536A, M3536J, M3536M, M3536MC
FDA device recall Z-1110-2014 · posted 2014-02-26 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems, Inc.
- Reason for recall
- HeartStart MRx Defibrillator Monitor therapy connection could experience accelerated wear causing risk for patients and/or caregivers
- Action taken
- Philips Medical North America issued on 2/4/14 the Urgent Medical Device Correction Notification/Field Safety Notice informs customers of 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 correction will consist of free of charge service support for the MRx therapy connection, including inspection of therapy connection, and installation of a stabilizing collar if not already present. If wear is detected, therapy components (including therapy pads/cables, CPR therapy cable, external paddles cable, and internal paddles cable/adapter) within their service life will be replaced. A Philips Healthcare representative will contact customers with affected devices to arrange for service. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Urgent Medical Device Correction notification/Field Safety Notice: You can continue to use your MRx prior to inspection and installation of upgrade hardware by a Philips Authorized Service Provider provided that upon receipt of this notification: Ensure you are performing ongoing therapy connection inspections on all of your MRx devices to detect wear. The HeartStart MRx Instructions for Use, 453564396411 Ed 1, 453564307761 Ed 2, or 453564174011, a previously circulated Therapy Connection Maintenance and Inspection When Used in Transport Addendum, Edition 6, describe how users can identify wear. If wear is detected, remove affected devices immediately from use and contact local Philips representative to arrange service or call 1-800-722-9377.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 58466 units
- Distribution
- Worldwide Distribution: USA (nationwide) and to countries of: AFGHANISTAN ALBANIA ARGENTINA ARUBA AUSTRALIA AUSTRIA AZERBAIJAN BAHRAIN BANGLADESH BELGIUM BOLIVIA BOSNIA AND HERZEGOWINA BRAZIL BRUNEI D
- Date initiated
- 2014-02-04
- Date posted
- 2014-02-26
- Date terminated
- 2020-09-03
- 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 |