Class 2 Device Recall HeartStart FR2 AED with ECG Display, Model 989803148611

• Date Initiated by Firm: September 22, 2010
• Date Posted: November 29, 2010
• Recall Status: Terminated on September 05, 2013
• Recall Number: Z-0488-2011
• Recall Event ID: 56816
• 510(K)Number: K003565 K013425 K0516332
• Product Classification: automatic external defibrillator - Product Code MKJ
• Product: HeartStart FR2+ AED with Text Display, Model 989803148611. This product is G2005 Update in accordance with the American Heart Association 2005 Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care (ECC).; ; The label of the device states: "HEARTSTART...FR2+ Automated External Defibrillator...Manufactured by: Philips Medical Systems Seattle, WA 98121".
• Code Information: Serial Numbers: 0205001035, 0307230040, 0307230281, 1204000353, 1204000405, and 1204000766.
• Recalling Firm/ Manufacturer: Philips Medical Systems; 2301 5th Ave Ste 200; Seattle WA 98121
• For Additional Information Contact: 800-263-3342
• Manufacturer Reason for Recall: A flash memory component in the HeartStart FR2+ and Automated External Defibrillator was improperly relabeled by a third party. Therefore the component could not be identified by its source, quality, and date of manufacture.
• FDA Determined Cause: Nonconforming Material/Component
• Action: On 10/5/10, Philips began sending out the Voluntary Medical Device Removal notification letter to their consignees. This letter informs the consignees that Philips Healthcare is conducting a voluntary product removal of a limited number of HeartStartFR2+ automated external defibrillators (AEDs), model numbers M3860A, M3861A, M3849A, and M3841A, manufactured by Philips and shipped between March 2007 and August 2010. The owners of affected AEDs are advised to run a battery insertion test. If it passes, the AED should remain in service until its replacement is received. Philips will be replacing affected units. The consignees can visit the firm's website www.philips.com/FR2AEDAction or contact Philips at 1-800-263-3342 for any information or support concerning the issue.
• Quantity in Commerce: 6 units
• Distribution: Devices were distributed to hospitals, medical facilities, and distributors through out the US and to foreign consignees. Foreign consignees including countries: Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Ecuador, El Salvador, Finland, France, French Guiana, Georgia, Germany, Ghana, Gibraltar, Guatemala, Hong Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Japan, Jordan, Kampuchea, Kenya, Korea, Latvia, Lebanon, Libya, Luxembourg, Malaysia, Malta & Gozo, Mexico, Netherland, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestinian Territory, Panama, Peru, Philippines, Portugal, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, United Arab Emirates, United Kingdom, Vietnam, and Zimbabwe.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MKJ and Original Applicant = AGILENT TECHNOLOGIES, INC.; 510(K)s with Product Code = MKJ and Original Applicant = PHILIPS MEDICAL SYSTEMS