—#95396

Product

Allura XPER FD10 F/C The intended uses of the Allura XPER X-ray systems involved with this report are angiographic X-ray systems with a solid state x-ray imaging device for cardiovascular and vascular diagnostic and interventional procedures.

FDA product code: IZI — System, X-Ray, Angiographic
Device class: Class 2
Medical specialty: Radiology
Affected lot / code info: Site numbers: 41444680, 41445250, 41445303, 41445766, 41446024, 41446262, 41622975, 42057739, 42799745, 42816302, 43151051, 43259235, 43270340, 43931289, and 43931292.

Why it was recalled

The Printed Circuit Board (PCB) in the Main-cabinet. Further investigation revealed that a manufacturing error in the PCB is responsible for the reliability issue. As a result, the complete system may shut down and not re-start.

Root cause (FDA determination)

Other

Action the firm took

Philips began mailing out an URGENT-Device Correction letter on May 26, 2009. Philips sent out a second URGENT-Device Correction letter dated June 4, 2009, to all consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were advised to contact their local Philips representative immediately if their system completely shut down and would not restart. A mandatory Field Change Order 72200144 was issued for replacement of the Printed Circuit Board (PCB) in the Allura XPER FD system. A mandatory Field Change Order FCO 70800091 was issued for replacement of the Printed Circuit Board (PCB) in the MultiDiagnost Eleva with FD system. The consignees were to be contacted by their Philips Representative for implementation of the corrective action. The firm's Field Engineer would replace the power tray of the systems. If the consignees needed any further information or support concerning this issue, they were to contact the call Center at 800-722-9377, # 5 and reference FCO 72200144 or FCO 70800091 with any questions.

Recalling firm

Firm: Philips Medical Systems North America Co. Phillips
Address: 22100 Bothell Everett Hwy, Bothell, Washington 98021-8431

Distribution

Distribution pattern: Nationwide Distribution including the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, OR, PA, RI, TN, TX, VA, and WI.

Timeline

Recall initiated: 2009-05-26
Posted by FDA: 2010-12-07
Terminated: 2010-12-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #95396. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.