Z-1044-2015Class II

Philips Multi Diagnost Eleva II

Name: Z-1044-2015 Philips Multi Diagnost Eleva II
Creator: Philips Medical Systems, Inc.
Published: 2013-10-14
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2013-10-14 / Terminated

FDA source

Philips Medical Systems, Inc. began a recall of Philips Multi Diagnost Eleva II on 2013-10-14. FDA classified it as Class II and gives the reason as "The possibility of the Reference Air Kerma Rate for low dose mode will not be reduced to 50% of the value for the normal mode, but will be approximately 70-80%, leading to a higher patient dose than expected". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1044-2015
Classification: Class II
Status: Terminated
Initiated: 2013-10-14
Posted: 2015-02-26
Terminated: 2017-01-23
Recalling firm: Philips North America LLC
Product: Philips Multi Diagnost Eleva II
Product code: IZI System, X-Ray, Angiographic
Reason for recall: The possibility of the Reference Air Kerma Rate for low dose mode will not be reduced to 50% of the value for the normal mode, but will be approximately 70-80%, leading to a higher patient dose than expected.
FDA root cause: Radiation Control for Health and Safety Act
Action: Philips Healthcare Planned Action: 1. Software updates to SW R6.1.3 through Field Change Orders (FCOs) FCO70800140 and FCO70800142. 2. A customer notification letter which includes a statement that Philips Healthcare will without charge, remedy the defect or bring the product into compliance. 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. Philips Healthcare will implement this CAP by September 1, 2015. For further questions please call (978) 687-1501.
Quantity in commerce: 238
Distribution: Worldwide Distribution - USA ( nationwide ) to the states of : AR, AZ, CA, CO, DE, FL, GA, HI, IL, IA, KY, KS, LA, MI, MO, MS, NC, NY, OH, PA, TN, TX, VA, VT, WA, WY and WV., and the countries of Austria, Australia, Colombia, Germany, Switzerland, Turkey, Ireland, Dubia and United Kingdom.
Product codes and lots: Product Code: 708036

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1044-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1044-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-04	2015-02-26
Z-1045-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-04	2015-02-26

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)