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Samaritan Pad 350P
- Starting date:
- June 28, 2017
- Posting date:
- July 17, 2017
- 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-63992
Reason
A customer complaint from Heartsine's Canadian distributor, Rescue 7, was received questioning why a SAM 350P, serial number 17D00009917, was labelled with an Omron Raing label. (Note: As well as the SAM 350p, Heartsine also manufacture a similar device for a Japanese customer, Omron. This Japanese device is referenced as the Omron HDF-3500 device. The rear label specific to the Omron HDF-3500 device is H045-013-013-1).
Affected products
Samaritan Pad 350P
Lot or serial number
17D00009913
17D00009914
17D00009915
17D00009916
17D00009917
17D00009918
17D00009919
17D00009920
17D00009921
17D00009922
Model or catalog number
SAM 350P
Companies
- Manufacturer
-
Heartsine Technologies Ltd.
Canberra House, 203 Airport Road West
Belfast, Northern Ireland
BT3 9ED
UNITED KINGDOM