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Philips Electronics North America Corporation Recall: Allura Xper FD10, FD10 C, and FD10 F

Philips Electronics North America Corporation Recall: Allura Xper FD10, FD10 C, and FD10 F is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Philips Electronics North America Corporation; Product: Allura Xper FD10, FD10 C, and FD10 F; Model Numbers: 722026 722010 722003 722002 722001 Int

Recalling firmPhilips Electronics North America Corporation
ProductAllura Xper FD10, FD10 C, and FD10 F; Model Numbers: 722026 722010 722003 722002 722001 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).
Reason for recallThe 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.
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusTerminated
DistributionWorldwide 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, Demo
Recall initiated20151103
Recall numberZ-0702-2016
Categorydevice
StateMA
CountryUnited States

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