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Health product recall

F7-01 Frame (2013-10-08)

Starting date:
October 28, 2013
Posting date:
November 29, 2013
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-36875

Recalled Products

F7-01 Frame

Reason

The PDM patient parameter acquisition module can somtimes spontaneously lose the communication with the host patient monitor when attached to the F5-01 frame of the Carescape monitor B850 due to an issue with the PDM ethernet communication hardware.

Affected products

F7-01 Frame

Lot or serial number

N/A

Model or catalog number

M1115509

Companies
Manufacturer
GE Healthcare Finland OY
Kuortaneenkatu 2,
Hesinki
00510
FINLAND