CLASS II Device recall · Reported 9 May 2018 · FDA Enforcement Report

MultiDim Eleva 708032 As a multifunctional universal recalled

Philips Medical Systems Nederlands is recalling MultiDim Eleva 708032 As a multifunctional universal imaging application system, General, distributed nationwide in the US. The recall was initiated on 26 Mar 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSystem Serial # 32 177 259 239 264 258 52 67 111 257 94 142 121 191 143 260 265 74 207 101 182 174 124 263 4 172 254 151 246 64 183 76 152 188 261 242 102 34 147 241 134 178 245 176 175 38 162 107 220 65 194 69 247 13 215 78 112 29 139 98 79 158 61 33 106 35 50 16 80 205 161 11 204 37 12 189 9 232 15 228 155 47 171 213 209 218 96 90 212 217 181 163 140 114 115 108 71 141 14 36 48 224 25 105 57 216 138 24 28 211 160 192 43 44 157 154 41 219 8 68 129 75 221 7 10 63 146 45 26 125 193 210 1 60 3 132 81 22 23 208 5 131 135 88 226 6 156 49 91 92 93 201 250 251 72 95 148 39 31 2 30 51 100 255 252 256 109 196 164 170 227 173 83 159 53 137 54 116 118 119 167 168 169 97

Quantity recalled184

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-1603-2018
FDA event ID: 79783
Recalling firm: Philips Medical Systems Nederlands, Best, N/A
Classification: Class II
Status: Terminated
Recall initiated: 26 Mar 2018
FDA classified: 3 May 2018
Reported: 9 May 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

26 Mar 2018	Recall initiated by company
3 May 2018	Classified by FDA	+38 days
9 May 2018	Published in enforcement report	+6 days

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

Reason for recall

The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will start to rotate from 0 to + 90 I- 90 degree with high speed. This rotating movement cannot be stopped by the user.

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

MultiDim Eleva 708032 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.

Where it was distributed

Worldwide Distribution: US (Nationwide) and countries of: Algeria, Argentina, Australia, Austria, Belgium, Canada, China, Colombia, Czech Republic, Denmark, Egypt, Estonia, Farce Islands, Finland, France, Germany, Hong Kong, Indonesia, Ireland, Israel, Italy, Jersey, Jordan, Korea, Republic of, Latvia, Lebanon, Luxembourg, Malaysia, Martinique Mexico, Netherlands, New Zealand, Norway, Oman, Philippines, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Turkey, United Arab Emirates, and United Kingdom.

Nationwide

Questions about this recall

Is MultiDim Eleva 708032 As a multifunctional universal imaging application system, General recalled?

Yes. Philips Medical Systems Nederlands recalled MultiDim Eleva 708032 As a multifunctional universal imaging application system, General on 26 Mar 2018. The recall is Class II and its status is Terminated. Recall number Z-1603-2018.

Why was it recalled?

Which lots are affected?

System Serial # 32 177 259 239 264 258 52 67 111 257 94 142 121 191 143 260 265 74 207 101 182 174 124 263 4 172 254 151 246 64 183 76 152 188 261 242 102 34 147 241 134 178 245 176 175 38 162 107 220 65 194 69 247 13 215 78 112 29 139 98 79 158 61 33 106 35 50 16 80 205 161 11 204 37 12 189 9 232 15 228 155 47 171 213 209 218 96 90 212 217 181 163 140 114 115 108 71 141 14 36 48 224 25 105 57 216 138 24 28 211 160 192 43 44 157 154 41 219 8 68 129 75 221 7 10 63 146 45 26 125 193 210 1 60 3 132 81 22 23 208 5 131 135 88 226 6 156 49 91 92 93 201 250 251 72 95 148 39 31 2 30 51 100 255 252 256 109 196 164 170 227 173 83 159 53 137 54 116 118 119 167 168 169 97

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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