Z-0985-2012

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

Name: Z-0985-2012 MultiDiagnost Eleva IITV (MD-EII) with Software Release: PBL 6.1.1 Product Code 708036
Creator: Philips Healthcare Inc.
Published: 2012-01-09
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2012-01-09 / Terminated / root cause: manufacturing process

FDA source

Philips Healthcare Inc. began a recall of 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... on 2012-01-09. The reason FDA records is "Incorrect Skin Dose calculation. AKR (Air Kerma Rate) displayed and stored in patient records is too low". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0985-2012
Status: Terminated
Initiated: 2012-01-09
Posted: 2012-02-08
Terminated: 2017-02-13
Recalling firm: Philips North America LLC
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.
Product code: IZI System, X-Ray, Angiographic
Reason for recall: Incorrect Skin Dose calculation. AKR (Air Kerma Rate) displayed and stored in patient records is too low
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: 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.
Quantity in commerce: 10 units (US)
Distribution: 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
Product codes and lots: Software Release: PBL 6.1.1

Product code IZI

K023441Class IIPhilips Multidiagnost ElevaPhilips Medical Systems / cleared 2002-10-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)