Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Heartstart (HS1) Laerdal brand onsite Automated External Defibrillator, Model M5067A

FDA Recall Z-1195-2010 · Posted 2010-03-23

Recalling FirmPhilips Medical Systems
Recall StatusTerminated
Product CodeMKJ
Date Initiated2009-11-02
Date Terminated2013-05-23
Product Quantity1 unit internationally

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.

K020715PHILIPS M5066A AND M5068APhilips Medical Systems · 2002-11-08

Official Source

View FDA Recall →

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

↑