—#95498

Product

HeartStart FR2+ AED with ECG Display, Model 989803148601. This product is G2005 Update according to 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".

FDA product code: MKJ — Automated External Defibrillators (Non-Wearable)
Device class: Class 3
Medical specialty: Cardiovascular
510(k) numbers: K003565, K013425
Affected lot / code info: Serial Numbers: 0205001561, 0307229836, 0307230439, 0407232904, and 1204000443.

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Philips Medical Systems
Address: 2301 5th Ave, Ste 200, Seattle, Washington 98121

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2010-09-22
Posted by FDA: 2010-11-29
Terminated: 2013-09-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #95498. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.