Device Recall Philips

IntelliSpace 4.4

Radiology Devices

2

No

US and Australia, Belgium, Canada, Egypt, France, Germany, Netherlands, Oman, Saudi Arabia, Spain, Switzerland, United Arab Emirates, United Kingdom.

Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.

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

Radiology Devices

2

No

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.

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.

All patient support for stitching are affected.

Radiology Devices

2

No

Distributed in the states of MN, KY, MA, VA, TX, NC, HI, FL, AZ, CT, and WY and the countries of Argentina, Australia, Austria, Canada, Denmark, Germany, Netherlands, Russia, Saudi Arabia, Singapore, Spain, and Switzerland.

Patient Support Material Number: 9890 010 87431 used with: BuckyDiagnost ; Model: 704060/706037

Software versions R5.1.7 and R5.1.8

Radiology Devices

2

No

Worldwide Distribution - USA (nationwide) and to the countries of: Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, Denmark Estonia, Ethiopia. France, Germany, Hong Kong, India, Indonesia, Iraq, Ireland, Italy, Japan, Jordan, Korea, Republic of, Libya, Malaysia, Mexico, Nepal, Netherlands, New Zealand, Norway, Oman, Palestinian territory, Peru, Poland, Russian Federation, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates and United Kingdom.

Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions R5.1.7 and R5.1.8 with the Mobi View software option. Diagnostic imaging system.

Software version 4.1.

Radiology Devices

2

No

US Distribution

Philips Brilliance iCT Computed Tomography X-Ray System || Product Usage: || The Brilliance iCT/Brilliance iCT SP is a Computed Tomography X-Ray System intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. (d) A description of the defect in the