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Health product recall

X Series/PropaqMD/PropaqM monitor/defibrillator running software version 02.10.02.00 or higher (2014-03-10)

Starting date:
March 10, 2014
Posting date:
June 5, 2014
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-39907

X Series/PropaqMD/PropaqM monitor/defibrillator running software version 02.10.02.00 or higher 

Reason

The device displayed an "internal error reset required" message and executed a system reset. This could occur while monitoring patients or may enter a continuous "System Reset" loop.

Affected products

X Series/PropaqMD/PropaqM monitor/defibrillator running software version 02.10.02.00 or higher

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

610-0120011-01

610-0221011-06

610-1221011-06

610-2211511-06

610-2221011-06

610-2221011-26

610-2221511-06

610-2241411-06

610-2241511-06

610-2320011-26

Companies

Manufacturer

Zoll Medical Corporation

269 Mill Road

Chelmsford

01824

Massachusetts

UNITED STATES