Recall Z-0204-2016— Philips Medical Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Philips Medical Systems, Inc., initiated 2014-11-19, terminated 2016-08-15. It names 6 FDA 510(k) clearances: K063375, K062233, K061707 and 3 more. Product: Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A. Reason: 1. Device will perform the weekly automated tests hourly, which could cause the therapy capacitors to degrade sooner than intended and 2. While connected to AC or DC power and with no battery installed or the battery installed has a charge level of less than 10%, the Ready for Use (RFU) indicator will not provide the expected low battery indication.
- Recalling firm
- Philips Medical Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-11-19
- Terminated
- 2016-08-15
- Firm location
- Andover, MA, United States
510(k) clearances named in this recall
6 on FDA's record- K063375 — HEARTSTART MRX, MODELS M3535A OR M3536A
- 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
Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A
Reason for recall
1. Device will perform the weekly automated tests hourly, which could cause the therapy capacitors to degrade sooner than intended and 2. While connected to AC or DC power and with no battery installed or the battery installed has a charge level of less than 10%, the Ready for Use (RFU) indicator will not provide the expected low battery indication
Data sourced from openFDA. This site is unofficial and independent of the FDA.