HeartStart FR2+ AED with Text Display (No ECG), Model M3861, Philips brand, no configurable manual charge. The label of

FDA device recall Z-0484-2011 · posted 2010-11-29 · Terminated

Recall details

Recalling firm

Philips Medical Systems

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

MKJ

Quantity affected

11, 158 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

Date initiated

2010-09-22

Date posted

2010-11-29

Date terminated

2013-09-05

Location

Seattle, WA

Related 510(k) clearances