Philips Healthcare Inc.

706037

Radiology Devices

2

No

Worldwide Distribution - Including USA.

Philips Healthcare EasyDiagnost Eleva DRF 4.0 || Stationary X-Ray System with DRF as an option for digital radiography.

722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025, 722001, 722003, 722008

Radiology Devices

2

No

Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Algeria, Argentina, Belgium, Brazil, Canada, Czech Rep, Chili, China, Columbia, Denmark, Egypt, France, Germany, India, Indonesia, Italy, Japan, Malaysia, Mexico, Morocco, Netherlands, Oman, Russia, Saudi Arabia, Singapore, South Korea, Spain, Thailand, United Kingdom, and Vietnam.

Allura X-ray System. || The Allura X-ray System is an angiographic X-ray system.

Model #s 712020, 712022, 712082 All systems with Eleva software version 2.x and stitching option.

Radiology Devices

2

No

Worldwide distribution: USA (nationwide) and countries of: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech. Rep, Denmark, Finland, France, Germany, Guadeloupe, India, Indonesia, Iran, Iraq, Italy, Japan, Malta, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Salkowski, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and Ver.Arab.Emir.

Philips Digital Diagnost Systems with Eleva software version 2.x and stitching option || Intended use: Stationary radiographic system, Radiographic system, digital

Serial Number Range CN14800101-CN14801360  CN21201362-CN21202440, CN21202525, SP13701043, USPP101007

Cardiovascular Devices

2

No

Worldwide Distribution-USA (nationwide) and the countries of AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, DENMARK, EL SALVADOR, FRANCE, GERMANY, ICELAND, INDIA, IRELAND ISRAEL, ITALY, JORDAN, KENYA, LEBANON, MALAYSIA,NAMIBIA NETHERLANDS, NORWAY, POLAND, PORTUGAL, RWANDA SAUDI ARABIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN SWITZERLAND, UNITED ARAB EMIRATES, and UNITED KINGDOM.

Philips SureSigns VSi/VS2+ patient monitors || Model Part Numbers || VSi/ 863275, 863276, 863277, || VS2+ 863278, 863279. || The SureSigns VS2+ vital signs monitor is for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility. The SureSigns VSi vital signs monitor is for measurement of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility

Lot or Serial Numbers With affected M-cabinet CXA;  Serial number; 11-K0003; 12-B0001, 12-B0002; 12-B0003

Radiology Devices

2

No

Worldwide Distribution - USA including OH and WA and the country of Canada

Philips DigitalDiagnost Systems with M Cabinet || Model: 712025 || Stationary radiographic system, digital-Universal RAD Applications