Devices

Device Recall Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of software

Model / Serial
All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of software
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution-US: AL AR AZ CA CO FL GA IL IN KS KY MA MI NY OH OR PA SC TX VA VT WA OUS: Argentina Australia Austria Bangladesh Belgium Brazil Canada Chile China Colombia Denmark Ecuador Estonia Ethiopia France Germany India Indonesia Iraq Ireland Italy Japan Jordan Korea, South Malaysia Mexico Netherlands New Zealand Norway Oman Palestine Poland Russian Federation South Africa Spain Sweden Switzerland Taiwan Turkey United Arab Emirates United Kingdom.
Product Description
All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of software. Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities.
Manufacturer
Philips Medical Systems, Inc.
1 Event
- Recall of Device Recall Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of software

Manufacturer

Philips Medical Systems, Inc.

Manufacturer Address
Philips Medical Systems, Inc., 3000 Minuteman Rd, Andover MA 01810-1032
Manufacturer Parent Company (2017)
Philips
Source
USFDA

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