Health product recall

HeartStart MRX Rechargeable Lithium Ion Battery (2018-10-27)

Starting date:
October 27, 2018
Posting date:
November 30, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-68466

Affected products

HeartStart MRX Rechargeable Lithium Ion Battery

Reason

Certain MRx M3538A lithium-ion batteries may contain a defective component. Should the component fail, the battery will no longer charge or deliver power to the MRx Monitor/Defibrillator, which may prevent operation of the device if a second charged battery is not installed or if the device is not connected to AC or DC power. Additionally, the LED status indicator on the battery will not illuminate, even if the battery has a charge. Should a second, unaffected battery be present in the HeartStart MRx, the battery failure may go unnoticed.

Affected products

HeartStart MRX Rechargeable Lithium Ion Battery

Lot or serial number

Not applicable

Model or catalog number

M3538A

Companies
Manufacturer

Philips Medical Systems

22100 Bothell Everett Highway

Bothell, Washington

98021

UNITED STATES