Z-0936-2012

Philips MultiDiagnost Eleva FD Software release: PBL 6.1.1 Product Code 708037

Name: Z-0936-2012 Philips MultiDiagnost Eleva FD Software release: PBL 6.1.1 Product Code 708037
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: software

FDA source

Philips Healthcare Inc. began a recall of 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... on 2012-01-09. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0936-2012
Status: Terminated
Initiated: 2012-01-09
Posted: 2012-02-02
Terminated: 2017-02-13
Recalling firm: Philips North America LLC
Product: 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.
Product code: IZI System, X-Ray, Angiographic
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 28 units (US)
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
Product codes and lots: Software release: PBL 6.1.1

Product code IZI

K050151Class IIMultidiagnost ElevaPhilips Medical Systems North America, Inc. / cleared 2005-02-09

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)