Z-1829-2012Class II

Philips Multi Diagnost Eleva II with swivel cable Product Codes; 708032, 708036 Multi Diagnost Eleva with...

Name: Z-1829-2012 Philips Multi Diagnost Eleva II with swivel cable Product Codes; 708032, 708036 Multi Diagnost Eleva with...
Creator: Philips Healthcare Inc.
Published: 2012-05-21
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2012-05-21 / Terminated / root cause: design

FDA source

Philips Healthcare Inc. began a recall of Philips Multi Diagnost Eleva II with swivel cable Product Codes; 708032, 708036 Multi Diagnost Eleva with FlatDetector with swivel cable Product Codes: 708034... on 2012-05-21. FDA classified it as Class II and gives the reason as "MultiDiagnost Eleva X--Ray system may have damage to System Cables from repeated movement". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1829-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-21
Posted: 2012-06-20
Terminated: 2017-01-18
Recalling firm: Philips North America LLC
Product: Philips Multi Diagnost Eleva II with swivel cable Product Codes; 708032, 708036 Multi Diagnost Eleva with FlatDetector with swivel cable Product Codes: 708034, 708037 This Philips MultiDiagnost Eleva system is intended to be used as a multifunctional/ universal system. General R/F, 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 Various . Arthrograms . Myelograms . Facet joint injections . Discography SialographyFluoroscopy, Radiography and Angiography
Product code: IZI System, X-Ray, Angiographic
Reason for recall: MultiDiagnost Eleva X--Ray system may have damage to System Cables from repeated movement
Root cause tag: design
FDA root cause: Device Design
Action: Philips Healthcare Imaging issued Urgent Field Safety Notice dated May 21, 2012, to accounts informing an inspection will be performed of the unit. The Cable guiding plate will be replaced. If the cables show any damage the complete cable set wll also be replaced. No action is be taken by the customer. For further information customers should call 1-800-722-9377. For questions regarding this recall call 978-687-1501.
Quantity in commerce: 433 units
Distribution: Worldwide Distribution - USA (nationwide) and the countries of: Nationwide Foreign: Australia Austria Belgium Bharain Canada China Columbia Czech Republic Denmark Dutch Antilles Egypt Estonia Finland France Germany Hong Kong Ireland Israel Italy Latvia Lebanon Luxembourg Malaysia Mexico Netherlands New Zealand Norway Philippines Qatar Russian Fed. Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Syria Taiwan Thailand Turkey United Kingdom
Product codes and lots: Units with cable swivel delivered from 2007

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1829-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1829-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-27	2012-06-20

Product code IZI

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)