Philips recall

Model M3516A Batteries used with Model M4735A HeartStart XL Monitor/Defibrillators [Consumable, Capital Equipment]

Battery Date of Manufacture Code: R-2011-12

Batteries manufactured in Taiwan

Geographic Regions: Worldwide

Manufacturer(s): Philips Healthcare North America [453551], 3000 Minuteman Rd, Andover, MA 01810-1099, United States

Problem: In a September 6, 2012, Urgent Medical Device Recall letter submitted by the manufacturer, Philips states that if the above batteries fail when the above monitor/defibrillators are not connected to an alternating current (AC) power source, the device may unexpectedly shut down without emitting a low-battery warning message or an audible tone. Philips also states that this problem may result in patient harm if the above monitor/defibrillators become inoperable when in clinical use for providing therapy (i.e., defibrillation, noninvasive pacing). Philips states that the above monitor/defibrillators can function on AC power without a battery.

Action Needed:

​Verify that you have received the September 6, 2012, Urgent Medical Device Recall letter from Philips. Identify any affected product in your inventory. Philips recommends that users operate affected monitor/defibrillators with AC power instead of battery power alone. If you need to operate the device on battery power alone, check the date of manufacture code to ensure that the battery is not affected by this problem. If you are unable to operate affected monitor/defibrillators on AC power or locate a different battery, Philips recommends that you use an alternative treatment or therapy (i.e., backup defibrillator/monitor). A Philips representative will contact your facility to arrange to replace affected batteries. Inform all relevant personnel at your facility of the information in the Urgent Medical Device Recall letter, and forward a copy of the letter to any facility to which you have further distributed affected product.

For Further Information:
Philips local representative
Tel: (800) 722-9377