Devices

Device Recall Flex SENSE Body Coil used with the the ACS NT, Intera 1.5T and Achieva 1.5T MR Philips MRI systems

Model / Serial
4522 131 5575x 4522 132 1985x 4522 132 7619x 4598 000 5187x 4598 000 5189x 4598 003 59051
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
US: Nationwide OUS: Canada, Afghanistan Albania Algeria Andorra Argentina Australia Austria Azerbaijan Bahamas Bangladesh Belarus Belgium Bolivia Bosnia and Herzegovina Botswana Brazil Burkina Faso Chile China Colombia Columbia Congo, Democratic Costa Rica Croatia Cyprus Czech Republic Denmark Dominican Republic Ecuador Egypt Estonia Ethiopia Finland France Georgia Germany Ghana Greece Guadeloupe Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Israel Italy Japan Jersey Jordan Kazakhstan Kenya Korea, Republic of Kuwait Kyrgyzstan Latvia Lebanon Libya Lithuania Luxembourg Malaysia Malta Martinique Mauritius Mexico Monaco Mongolia Morocco Mozambique Nepal Netherlands New Caledonia New Zealand Norway Oman Pakistan Palestinian territory, occupied Panama Papua New Guinea Peru Philippines Poland Portugal Puerto Rico Romania Russian Federation Rwanda Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sri Lanka Sudan Sweden Switzerland Syrian Arab Republic Taiwan Tanzania Thailand Tunisia Turkey Uganda Ukraine United Arab Emirates United Kingdom Venezuela Viet Nam Yemen Zimbabwe
Product Description
SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T and Achieva 1.5T MR system
Manufacturer
Philips Electronics North America Corporation
1 Event
- Recall of Device Recall Flex SENSE Body Coil used with the the ACS NT, Intera 1.5T and Achieva 1.5T MR Philips MRI systems

Manufacturer

Philips Electronics North America Corporation

Manufacturer Address
Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
Manufacturer Parent Company (2017)
Philips
Source
USFDA

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