Health product recall

McKesson Cardiology Hemo (2018-12-15)

Starting date:
December 15, 2018
Posting date:
January 9, 2019
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-68660

Affected products

McKesson Cardiology Hemo

Reason

Change Healthcare has identified an issue with specific versions of the Schiller PB-1000, a critical component of the Horizon Cardiology Hemo and McKesson Cardiology Hemo systems.  Due to this issue, non-invasive blood pressure (NIBP) measurements may not be available, as the NIBP pump may fail to inflate the NIBP cuff to the required pressure.

Affected products

McKesson Cardiology Hemo

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

D208267

Companies
Manufacturer

Change Healthcare Israel Ltd.

26 HaRokmim St.Azriel Center, Building A

Holon

5885849

ISRAEL