Device Recall Philips

2

No

Nationwide Distribution

Allura Xper Systems Models: || Allura Xper FD10 (F/C)-Biplane Fixed || Allura Xper FD10/10 (incl. OR table) || Allura Xper FD20- High resolution fixed-x ray || Allura Xper FD20/10 || Allura Xper FD20/20 || Allura CV20 || The Allura Xper F010, FD10/10, FD20, FD20/10 and FD20/20 Use From Labeling): is intended for use in cardiovascular and vascular X-ray imaging applications. including diagnostic,interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP). The Allura Xper is intended for: Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral. thoracic and abdominal angiography, as well as PTCAs. stent placements, embolisations and thrombolysis. and Cardiac imaging applications including diagnostics, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations and Electrophysiology (EP). Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures. Use of the Allura Xper FD Series in the OR environment is restricted; the system should only be used for minimally invasive procedures. (Endovascular)

2

No

Worldwide Distribution -- USA, Belgium, Canada, Chile, Columbia, Egypt, India, Italy, Spain, Saudi Arabia Thailand, GB, and Russia.

PHILIPS NM3 Monitor Model Number: 7900 || PHILIPS NM3 Monitor, English || Part Number: 1051674 || PHILIPS NM3 Monitor, English, Refurbished || Part Number : U1051674 || PHILIPS NM3 Monitor, English, Demo Unit || Part Number: DU1051674 || PHILIPS NM3 Monitor, Spanish || Part Number: 1060462 || PHILIPS NM3 Monitor, French Part Number: 1060458 || PHILIPS NM3 Monitor, Swedish Part Number:1062860 || Intended use: Cardiac output monitoring, Spirometric and carbon dioxide monitoring, and Continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate.

2

No

Worldwide Distribution: Nationwide distribution; and including the countries of Albania, Angola, Argentina, Australia, Austria, Azerbaijan, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Croatia, Denmark, Egypt, France, Germany, Ghana, Greece, Greece, Haiti, Hungary, Indonesia, Iraq, Israel, Italy, Kazakhstan, Kenya, Latvia, Libya, Liechtenstein, Lithuania, Malawi, Malta, Martinique, Mexico, Mozambique, Netherlands, New Zealand, Nigeria, Norway, Oman, Philippines, Portugal, Puerto Rico, Romania, Russia, Saudi-Arabia, Serbia, Slovakia, South Africa, Spain, Sudan, Sweden, Switzerland, Tanzania, Thailand, Tschech. Rep, Turkey, Turkmenistan, UAE, Uganda, and United Kingdom.

PCR Eleva Radiological Image Processing System with software R.1.2 || Philips Healthcare, Inc. || A computed radiography image processing system.

2

No

Worldwide Distribution - USA (nationwide) including the states of CA, IL, OH, SD, TX, WY and the countries of: Australia, Austria, Canada, Egypt, Germany, mexico, Turkey and UK

MultiDiagnost Eleva IITV (MD-EII) with Software Release: PBL 6.1.1 || Product Code 708036 || Product Usage: || The Philips MultiDiagnost Eleva system is intended to be used as a multifunctional/universal system. General R/F, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications. This includes the following general areas: Digestive system, Skeletal system, Urinary system, Reproductive system, Respiratory system, Circulatory system, and Various: Arthrograms, Myelograms, Facet joint injections, Discography, Sialography.

2

No

Worldwide Distribution - Nationwide Distribution (USA) including the states of AR, AZ, CA, CO, FL, IA, KS, LA, MI, MO, NC, NY, OH, PA, TX, VA, VT, WA and WV

Philips MultiDiagnost Eleva FD Software release: PBL 6.1.1 || Product Code 708037 || Product Usage: || The Philips MultiDiagnost Eleva system is intended to be used as a multifunctional/universal system. General R/F, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications. This includes the following general areas: Digestive system, Skeletal system, Urinary system, Reproductive system, Respiratory system, Circulatory system, and Various: Arthrograms, Myelograms, Facet joint injections, Discography, Sialography.