MultiDiagnost Eleva with FD. The Philips MultiDiagnost Eleva intended use is for the following applications: As a diagno

FDA device recall Z-0544-2011 · posted 2010-12-07 · Terminated

Recall details

Recalling firm

Philips Medical Systems North America Co. Phillips

Reason for recall

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

IZI

Quantity affected

5 units

Distribution

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.

Date initiated

2009-05-26

Date posted

2010-12-07

Date terminated

2010-12-09

Location

Bothell, WA