FD10 C, FD10 F, Cl II Philips Allura Xper FD10

Company: Philips Electronics North America Corporation
Date of Enforcement Report 2/102016
Class lI:

PRODUCT

Allura 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).
Recall Number Z-0702-2016

REASON
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.

RECALLING FIRM/MANUFACTURER
Philips Electronics North America Corporation, Andover, MA on 11/3/2015. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
13297 in total

DISTRIBUTION
Nationwide and Internationally

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Partners located in the US (CA, FL, MA, MN) and Italy.