Recalls / —

—#29254

Product

Model M4735A HeartStart XL Defibrillator//Monitor

FDA product code

MKJ — Automated External Defibrillators (Non-Wearable)

Device class

Class 3

Medical specialty

Cardiovascular

510(k) numbers

K021453

Affected lot / code info

Units with software versions A.02.00 or greater

Why it was recalled

Instructions For Use include addtional information on configuration for selecting Power on Lead

Root cause (FDA determination)

Other

Action the firm took

Philips Medical in conjunction with NNC (National Notification Center) notified users by letter on 9/2/03. Users are provided with Addendum to the HeartStart XL Instructions for Use (to be added to the Instruction for Use) and to familiarize with the configurable Power on Lead. Users are rquested to acknowledge receipt by returning the Business reply Card.

Recalling firm

Firm

Philips Medical Systems

Address

3000 Minuteman Road, Andover, Massachusetts 01810

Distribution

Distribution pattern

NATIONWIDE Foreign: Canada, Argentina, Brazil, Chile, Costa Rica, Mexico, Paraguay, Peru, Venezuela, Austalia, China,Hong Kong, India, Japan, Malaysia, Manilla, New Zealand, Manila, Singapore,Taiwan,Thailand, Vietnam, ALgeria, Australia,France,Italy, Netherlands,Norway,Oman,Poland, Portugal,South Africa, Spain, Sri Lanka, Sweden, Switzerland, Tunisia, Turkey, UK

Timeline

Recall initiated

2003-09-02

Posted by FDA

2003-09-11

Terminated

2005-04-20

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #29254. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.