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Terminated

Philips HeartStart FR2+ Defibrillator Automated External Defibrillator (AED) Catalog Numbers: M3860A/M3861A/M3840A/M3841A

FDA Recall Z-0641-2007 · Posted 2007-03-22

Recalling FirmPhilips Medical Systems
Recall StatusTerminated
Product CodeMKJ
Date Initiated2007-02-28
Date Terminated2013-11-13
Product Quantity9099 units

Reason for Recall

Failure of tactile switches on one of two printed circuit board assemblies (PCBA) used in the FR2+ device. Potential delay or prevention of shock treatment due to PCBA board contamination, causing intermittent switch operation.

Firm Action

On 02/28/2007 the firm sent letters via return receipt to all domestic and foreign customers. The letter advises the customer of the issue and if the user encounters the problem, to press the button again with additional force. In addition, the firm sent with the letter a new Quick Reference Card. Customers are instructed to replace the old Quick Reference Card with the new one which instructs them to press 'On' and 'Shock' buttons firmly.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Distribution is worldwide. Devices are used by first responders (EMT, EMS, Fire and Police personnel, etc.), and by trained personnel on commercial airlines and business offices.

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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