Z-0487-2011

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

Name: Z-0487-2011 HeartStart FR2+ AED with ECG Display, Model 989803148601. This product is G2005 Update according to the...
Creator: Philips Medical Systems
Published: 2010-09-22
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2010-09-22 / Terminated / root cause: manufacturing process

FDA source

Philips Medical Systems began a recall of HeartStart FR2+ AED with ECG Display, Model 989803148601. This product is G2005 Update according to the American Heart Association 2005 Guidelines for... on 2010-09-22. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0487-2011
Status: Terminated
Initiated: 2010-09-22
Posted: 2010-11-29
Terminated: 2013-09-05
Recalling firm: Philips North America LLC
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".
Product code: MKJ Automated External Defibrillators (Non-Wearable)
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.
Root cause tag: manufacturing process
FDA root 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: 5 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.
Product codes and lots: Serial Numbers: 0205001561, 0307229836, 0307230439, 0407232904, and 1204000443.

Product code MKJ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)