Recalls / —

—#73235

Product

Philips HeartStart FRx Defibrillator, Automated External Defibrillator (AED), catalog number 861304.

FDA product code

MKJ — Automated External Defibrillators (Non-Wearable)

Device class

Class 3

Medical specialty

Cardiovascular

510(k) numbers

K050004

Affected lot / code info

Serial Number: B08G-01884

Why it was recalled

The affected device may not deliver appropriate defibrillation therapy.

Root cause (FDA determination)

Employee error

Action the firm took

Philips notified the customer with the affected device by phone on August 8, 2008 . A replacement device was shipped to the customer on August 11, 2008.

Recalling firm

Firm

Philips Medical Systems

Address

2301 5th Ave, Ste 200, Seattle, Washington 98121

Distribution

Distribution pattern

Nationwide Distribution: to one account in Arkansas.

Timeline

Recall initiated

2008-08-07

Posted by FDA

2010-11-22

Terminated

2010-12-01

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #73235. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.