FDA Recall Terminated

Philips MultiDiagnost Eleva FD Software release: PBL 6.1.1 Product Code 708037 Product Usage: The Philips MultiDiagnost Eleva system is intended to be used as a multifunctional/universal system. General R/F, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications. This includes the following general areas: Digestive system, Skeletal system, Urinary system, Reproductive system, Respiratory system, Circulatory system, and Various: Arthrograms, Myelograms, Facet joint injections, Discography, Sialography.

Recall: Z-0936-2012 · Initiated January 9, 2012

Recall

Recall Number: Z-0936-2012
Event Number: 60936
Firm: Philips Healthcare Inc.
FEI Number: 1218950
Product Code: IZI
Status: Terminated
Root Cause: Software design
Initiated: January 9, 2012
Posted: February 2, 2012
Terminated: February 13, 2017
Address: 3000 Minuteman Road, Andover, MA, 01810

Description

Reason

The skin dose and skin dose rate values are calculated using an incorrect point of reference. Therefore, the AKR as displayed and stored in patient records is too low, although the dose as received by the patient is not affected.

Action

Philips Healthcare issued on January 9, 2012 a mandatory Field Safety Notice to all affected customers. The letter identified the affected product, problem description, hazard involved and actions that should be taken by the customer/user. The letter contains important information for the continued safe and proper use of the equipment. Customers were instructed to review the following information with all members of there staff and retain a copy with the equipment "Instruction for Use". For information or support concerning this notice contact your local Philips representative 866-767-2822.

Distribution

Worldwide Distribution - Nationwide Distribution (USA) including the states of AR, AZ, CA, CO, FL, IA, KS, LA, MI, MO, NC, NY, OH, PA, TX, VA, VT, WA and WV

Quantity

28 units (US)