Recall Z-1660-2014— Physio-Control, Inc.
Class II · Terminated
Class II FDA medical device recall by Physio-Control, Inc., initiated 2014-05-09, terminated 2018-05-29. It names one FDA 510(k) clearance: K042404. Product: LIFEPAK 1000 defibrillator. Affected Part Numbers: 320371500XXX The LP1000 (in AED mode) is indicated for use on patients in cardiac arrest.. Reason: Physio-Control has become aware of incidents where customers have attempted to use their LIFEPAK 1000 defibrillator and the device has shut down unexpectedly due to a very low battery. A defibrillator in this scenario has the potential to fail to deliver a shock, with the potential result that therapy is not delivered and a patient is not resuscitated. A software malfunction in the LIFEPAK 100.
- Recalling firm
- Physio-Control, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-05-09
- Terminated
- 2018-05-29
- Firm location
- Redmond, WA, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
LIFEPAK 1000 defibrillator. Affected Part Numbers: 320371500XXX The LP1000 (in AED mode) is indicated for use on patients in cardiac arrest.
Reason for recall
Physio-Control has become aware of incidents where customers have attempted to use their LIFEPAK 1000 defibrillator and the device has shut down unexpectedly due to a very low battery. A defibrillator in this scenario has the potential to fail to deliver a shock, with the potential result that therapy is not delivered and a patient is not resuscitated. A software malfunction in the LIFEPAK 100
Data sourced from openFDA. This site is unofficial and independent of the FDA.