Z-2156-2012Class II

Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034

Name: Z-2156-2012 Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034
Creator: Philips Healthcare Inc.
Published: 2012-07-11
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2012-07-11 / Terminated / root cause: software

FDA source

Philips Healthcare Inc. began a recall of Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 Product Usage: Philips X-ray System on 2012-07-11. FDA classified it as Class II and gives the reason as "When doing a 3 Dimensional Rotational Angiography (3DRA) the 3D reconstruction does not always start, even when all images have been acquired". 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-2156-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-11
Posted: 2012-08-08
Terminated: 2013-03-26
Recalling firm: Philips North America LLC
Product: Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 Product Usage: Philips X-ray System
Product code: KPR System, X-Ray, Stationary
Reason for recall: When doing a 3 Dimensional Rotational Angiography (3DRA) the 3D reconstruction does not always start, even when all images have been acquired.
Root cause tag: software
FDA root cause: Software design
Action: Philips issued an Urgent Field Safety Notice dated July 2, 2012 to all affected customers. The letter identified the affected product, problem description, actions to be taken by the customer/user in order to prevent risks for patients or users and actions planned by Philips to correct the problem. For question or support concerning this issue contact your local Philips representative.
Quantity in commerce: 41 units
Distribution: Worldwide Distribution - US (nationwide) including the states of CA, CT, MI, MN, MN, NC, NY, NY, VA and the countries of Belgium, Columbia, Czech Republic and Denmark. France Germany Italy Latvia Luxembourg Netherlands Russian Fed. Spain Sweden Switzerland Thailand United Kingdom
Product codes and lots: US Serial Numbers: 96 104 111 120 170 222 223 272 278 WW: 41 70 83 96 104 111 120 132 154 155 156 157 167 170 171 176 179 190 194 195 200 208 216 222 223 224 237 244 245 247 248 249 251 253 259 261 262 264 265 272 278

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2156-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2156-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-15	2012-08-07

Product code KPR

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)