CLASS II Device recall · Reported 15 Aug 2012 · FDA Enforcement Report

Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD) recalled

Philips Healthcare is recalling Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD), distributed nationwide in the US. The recall was initiated on 11 Jul 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUS 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

Quantity recalled41 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-2156-2012
FDA event ID: 62551
Recalling firm: Philips Healthcare, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 11 Jul 2012
FDA classified: 7 Aug 2012
Reported: 15 Aug 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

11 Jul 2012	Recall initiated by company
7 Aug 2012	Classified by FDA	+27 days
15 Aug 2012	Published in enforcement report	+8 days

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

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 Product Usage: Philips X-ray System

Where it was distributed

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

Nationwide California Connecticut Michigan Minnesota North Carolina New York Virginia

Questions about this recall

Is Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD) recalled?

Yes. Philips Healthcare recalled Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD) on 11 Jul 2012. The recall is Class II and its status is Terminated. Recall number Z-2156-2012.

Why was it recalled?

When doing a 3 Dimensional Rotational Angiography (3DRA) the 3D reconstruction does not always start, even when all images have been acquired.

Which lots are affected?

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

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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