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Terminated

HeartStart FR2+ Defibrillator

FDA Recall Z-0308-2007 · Posted 2006-12-27

Recalling FirmPhilips Medical Systems
Recall StatusTerminated
Product CodeMKJ
Date Initiated2006-12-19
Date Terminated2011-06-22
Product Quantity2000 units

Reason for Recall

Potential for shock treatment to be delayed or prevented due to board contamination that causes intermittent switch operation

Firm Action

On 12/19/06 the firm sent letters via return receipt to all domestic customers. The letter advised customers of the issue and if the user encounters the problem, to press the button again with additional force. The users are to contact Philips for replacement. The devices can be used until the user receives a replacement.

Root Cause

Process design

Distribution Pattern

Distribution is worldwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K003565HEARTSTREAM FR2 AED, MODEL M3860A,M3861AAgilent Technologies, Inc. · 2000-12-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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