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Terminated

Heartstart HS1 Defibrillator Model M5068A

FDA Recall Z-1196-2010 · Posted 2010-03-23

Recalling FirmPhilips Medical Systems
Recall StatusTerminated
Product CodeNSA
Date Initiated2009-11-02
Date Terminated2013-05-23
Product Quantity34 units distributed domestically

Reason for Recall

Potential for failure of a capacitor during use which would prevent the AED from delivering effective defibrillation therapy when indicated.

Firm Action

The firm notified their US distributors of the recall and instructed them to contact customers and provide information how to return the product to Philips for a free replacement. Firm contacted distributors via phone and email on 11/2/09 and by letter on 11/9/09. A web site providing information related to the recall was activated on 11/3/09.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K040904PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068APhilips Medical Systems · 2004-09-16

Official Source

View FDA Recall →

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

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