Philips Electronics North America Corporation recalls Allura Xper FD10 OR Table; Model Numbers: 722033 722022 Intended for Cardiovascular and vascular X-ray imaging applic

Recalled February 10, 2016 · FDA recall Z-0704-2016 · Philips Electronics North America

Hazard

The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. · FDA Class II

Units

13297 in total

Sold at

Worldwide Distribution: US (Nationwide) including Puerto Rico and countries of: Albania, Algeria, US Virgin Islands, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Democratic Congo, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.

Description

The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.

Product

Allura Xper FD10 OR Table; Model Numbers: 722033 722022 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP).

Manufacturer(s)

Philips Electronics North America Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →