CLASS II Device recall · Reported 27 Jun 2012 · FDA Enforcement Report

Philips Multi Diagnost Eleva II with swivel cable Product Codes recalled

Philips Healthcare is recalling Philips Multi Diagnost Eleva II with swivel cable Product Codes, distributed nationwide in the US. The recall was initiated on 21 May 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUnits with cable swivel delivered from 2007

Quantity recalled433 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1829-2012
FDA event ID: 62052
Recalling firm: Philips Healthcare, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 21 May 2012
FDA classified: 20 Jun 2012
Reported: 27 Jun 2012
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Other Reasons
Device type: CPAP & Ventilators

Timeline

21 May 2012	Recall initiated by company
20 Jun 2012	Classified by FDA	+30 days
27 Jun 2012	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

MultiDiagnost Eleva X--Ray system may have damage to System Cables from repeated movement

Product as listed by the FDA

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

Where it was distributed

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

Nationwide

Questions about this recall

Is Philips Multi Diagnost Eleva II with swivel cable Product Codes recalled?

Yes. Philips Healthcare recalled Philips Multi Diagnost Eleva II with swivel cable Product Codes on 21 May 2012. The recall is Class II and its status is Terminated. Recall number Z-1829-2012.

Why was it recalled?

MultiDiagnost Eleva X--Ray system may have damage to System Cables from repeated movement

Which lots are affected?

Units with cable swivel delivered from 2007

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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