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U.S. Department of Health and Human Services

Class 2 Device Recall MultiDiagnost Eleva

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  Class 2 Device Recall MultiDiagnost Eleva see related information
Date Initiated by Firm February 28, 2019
Create Date March 23, 2019
Recall Status1 Terminated 3 on August 03, 2020
Recall Number Z-1055-2019
Recall Event ID 82313
510(K)Number K050151  
Product Classification System, x-ray, stationary - Product Code KPR
Product MultiDiagnost Eleva w/ Flat Detector, Product codes 708034, 708037, 708038
Product Usage:
As a multifunctional I universal imaging application system, General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications on human patients. This includes the following general areas: Digestive system: Swallowing studies, Oesophagus, Stomach, Small intestine, Colon, Defeacography, ERCP, T-tube cholangiogram, Liver biopsies, Transjugular Intrahepatic Portosystemic Shunts (TIPS) Skeletal system: Bone studies. Urinary system: IVP, Cystograms, Percutaneous, Nephrolithotomy, Nephrostomy tube replacement Reproductive system: Hysterosalpingogram, Vena spermatica, Cavernography Respiratory system: Thorax, Bronchoscopy, Pulmonary biopsies Circulatory system: Venography, Arteriography, Thrombolytic Therapy, Em bolizations, Em bolectomy, IVC filter placement, Dilatations, Stent placement. Various: Arthrograms, Myelograms, Facet joint injections, Discography, Sialography.
Code Information Serial numbers 1 2 2 2 3 3 4 4 4 5 5 5 6 6 6 7 7 8 8 8 9 9 10 10 10 11 11 12 12 12 13 13 13 14 14 14 15 15 15 16 16 17 17 18 18 19 19 20 21 22 22 22 23 23 23 24 24 24 25 25 25 26 26 26 27 27 28 28 29 29 29 30 30 30 31 31 31 32 32 32 33 33 33 34 34 34 35 35 35 36 36 36 37 37 38 38 38 39 39 39 40 40 41 41 41 42 42 43 43 43 44 44 44 45 45 46 46 47 47 47 48 48 48 49 49 50 50 50 51 51 51 52 52 53 53 53 54 54 54 55 55 56 56 57 57 58 58 59 60 60 60 61 61 62 62 63 63 63 64 64 64 65 65 65 66 66 67 67 68 68 69 69 69 70 70 71 71 71 72 72 72 73 73 73 74 75 75 76 76 76 77 78 78 79 79 79 80 80 80 81 81 81 82 82 83 83 83 84 84 85 85 86 87 88 88 88 89 90 90 91 91 92 92 93 93 93 94 94 94 95 95 95 96 96 96 97 97 97 98 98 98 99 99 100 100 100 101 101 101 102 102 103 103 104 105 105 105 106 106 106 107 107 108 108 109 109 110 110 111 111 111 112 112 112 113 113 114 114 114 115 115 115 116 116 116 117 117 118 118 118 119 119 119 120 120 121 121 121 122 123 123 124 124 125 125 125 126 126 126 127 128 128 129 129 129 130 131 131 132 132 132 133 133 134 134 135 135 135 136 136 137 137 138 138 139 139 140 140 141 141 142 142 142 143 143 144 144 146 146 146 147 147 148 148 148 149 149 149 150 150 151 151 151 152 152 152 153 154 154 154 155 155 155 156 156 156 157 157 157 158 158 159 159 159 160 160 160 161 161 161 162 162 163 163 163 164 164 165 167 167 168 168 169 169 170 170 170 171 171 171 172 172 172 173 173 174 174 174 175 175 175 176 176 176 177 177 177 178 178 179 179 180 180 181 181 181 182 182 182 183 183 183 184 185 185 186 187 187 188 188 189 189 189 190 190 191 191 191 192 192 193 193 193 194 194 195 195 196 196 196 197 197 198 199 199 200 200 201 201 201 202 202 203 204 204 205 205 205 206 206 207 207 207 208 208 209 209 209 210 210 211 211 212 212 212 213 213 213 214 215 216 216 217 217 217 218 218 219 219 219 220 220 221 221 221 222 222 223 224 224 225 226 226 227 227 228 228 228 229 230 232 233 233 234 234 235 235 236 236 237 237 238 238 239 239 240 240 241 241 241 242 242 243 244 244 244 245 245 245 246 246 246 247 247 248 248 249 249 249 250 251 251 252 253 253 254 254 255 255 256 257 257 258 259 259 260 261 261 262 262 263 264 264 265 265 266 268 268 269 272 273 277 278 60268 NTS0427 
Recalling Firm/
Manufacturer		 Philips North America, LLC
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact Roland Telson
978-659-7275
Manufacturer Reason
for Recall		 The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user.
FDA Determined
Cause 2		 Component design/selection
Action On February 28, 2019, the firm notified customers via an Urgent Field Safety Notice letter. The letter informed customers that the affected systems would be inspected for missing locking plates. Customers were asked to place a copy of the Field Safety Notice with the documentation of the system until the system has been inspected by Philips. Philips will inspect all potentially affected systems free of charge. If a locking plate is found missing, Philips will secure the system until a locking plate is installed so that use of the system can continue. You will be contacted by your local Philips representative to schedule the inspection. Philip's action will start effective from March 2019. If you need further information or support concerning this issue, please contact your local Philips representative.
Quantity in Commerce 1969
Distribution US Nationwide domestic distribution, and worldwide international distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KPR and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
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