LIFEPAK 20 defibrillator/monitor. The device is an AC powered defibrillator device with battery backup. The defibrillators are primarily used by healthcare providers in device user facilities such as hospitals and clinics.
FDA Recall Z-0925-2007 · Posted 2007-06-09
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Recalling FirmMedtronic Emergency Response Systems, Inc.
Recall StatusTerminated
Product CodeMJK
Date Initiated2007-04-27
Date Terminated2012-03-23
Product Quantity859 units
Reason for Recall
White Screen Lock up: LifePak 20 defibrillators with software version 48 or version 52 may experience an intermittent timing issue during the power on sequence. This may lock up the device resulting in the monitor screen going white, and may cause a potential delay or prevention of shock treatment.
Firm Action
On 04/27/2007 firm sent letters via return receipt to all domestic and foreign customers. The letter recommends for customers to turn the defibrillator power off and back on to restore normal operation in the event of a white screen condition. In addition, the letter advises that a representative from the firm will contact customer to make arrangements to provide a software upgrade to correct the issue.
Root Cause
Other
Distribution Pattern
Distribution is Worldwide. Devices are used by healthcare providers in hospital or healthcare clinic settings.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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