Recall Z-1417-2017— Philips North America, LLC
Class I · Terminated
Class I FDA medical device recall by Philips North America, LLC, initiated 2017-02-24, terminated 2020-04-17. It names 5 FDA 510(k) clearances: K062233, K061707, K051134 and 2 more. Product: HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9. Reason: HeartStart MRx Monitor/Defibrillator may may exhibit abnormal behavior when operating using a single battery as the sole source of power may fail to deliver therapy or monitoring.
- Recalling firm
- Philips North America, LLC
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2017-02-24
- Terminated
- 2020-04-17
- Firm location
- Andover, MA, United States
510(k) clearances named in this recall
5 on FDA's record- K062233 — HEARTSTART MRX MONITOR/DEFIBRILLATOR
- K061707 — HEARTSTART MRX, INVASIVE PRESSURE & TEMPERATURE OPTIONS
- K051134 — HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536A
- K040404 — HEARTSTART MRX, MODEL M3535A
- K031187 — HEARTSTART MRX, MODEL M3535A
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9
Reason for recall
HeartStart MRx Monitor/Defibrillator may may exhibit abnormal behavior when operating using a single battery as the sole source of power may fail to deliver therapy or monitoring
Data sourced from openFDA. This site is unofficial and independent of the FDA.