—#102144

Product

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)

FDA product code: IZI — System, X-Ray, Angiographic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K031333, K033737, K041949
Affected lot / code info: Software releases: PBL 6.5.1 1PBL 6.5.2 1PBL 7.0.x 1PBL 7.2.x

Why it was recalled

System freezes from 20 seconds up to one minute. No fluoroscopy exposure and no geometry movements during this time period.

Root cause (FDA determination)

Software design

Action the firm took

Philips Health Care North America sent a FIELD SAFETY CORRECTION ACTION letter dated July 4, 2011, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. This FCD will be identified as FCD72200200 and will be free of charge. This FCD consists a CD with the correct firmware and a installation procedure to implement the FCD correctly. Please contact your local Philips representative. For further follow up please call (978 ) 687-1501.

Recalling firm

Firm: Philips Healthcare Inc.
Address: 3000 Minuteman Road, Andover, Massachusetts 01810

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2011-07-08
Posted by FDA: 2011-08-10
Terminated: 2014-05-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #102144. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.