—#106736

Product

MultiDiagnost Eleva IITV (MD-EII) with Software Release: PBL 6.1.1 Product Code 708036 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.

FDA product code: IZI — System, X-Ray, Angiographic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K023441
Affected lot / code info: Software Release: PBL 6.1.1

Why it was recalled

Incorrect Skin Dose calculation. AKR (Air Kerma Rate) displayed and stored in patient records is too low

Root cause (FDA determination)

Employee error

Action the firm took

Philips Healthcare issued a mandatory Urgent Field Safety Noticedated October 3, 2011 to all affected customers. The letter identifies the affected product, problem description, hazard involved, action to be taken by customer/user and actions planned by Philips to correct the problem. The letter provide important information for the continued safe and proper use of the equipment. The letter instructs customers to review the following information with all members of their staff who need to be aware of the contents of this communication and retain a copy with the equipment Instruction for Use. For further information or support concerning this issue contact your local Philips representative at 866-767-2822.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) including the states of CA, IL, OH, SD, TX, WY and the countries of: Australia, Austria, Canada, Egypt, Germany, mexico, Turkey and UK

Timeline

Recall initiated: 2012-01-09
Posted by FDA: 2012-02-08
Terminated: 2017-02-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #106736. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.