MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708034 708037 708038
FDA Device Recall #Z-1489-2020 - Class II, December 30, 2019
Recall Summary
| Recall Number | Z-1489-2020 |
| Classification | Class II - Moderate risk |
| Date Initiated | December 30, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Philips North America, LLC |
| Location | Andover, MA |
| Product Type | Devices |
| Quantity | 534 |
Product Description
MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708034 708037 708038
Reason for Recall
A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.
Distribution Pattern
Nationwide domestic distribution. Foreign distribution worldwide.
Lot / Code Information
Serial Codes 32 177 98 18 42 40 239 228 123 235 152 107 90 26 239 272 88 258 52 111 67 111 85 257 46 94 129 142 121 172 191 41 143 185 36 129 32 81 136 120 159 236 114 113 181 109 124 244 238 23 82 65 57 91 15A 249 259 74 207 101 182 101 174 70 124 34 138 188 142 86 35 37 128 47 118 4 178 158 172 27 43 117 148 149 10 45 203 79 47 229 151 7 5 24 64 184 183 76 173 58 199 29 119 34 407 126 524617 152 188 71 52 60 242 244 52 393 346 49 102 47 197 198 34 147 87 134 178 237 105 176 190 241 397 36 245 13 187 175 38 162 107 76 220 65 15 26 194 81 126 217 69 124 184 107 139 35 13 15 373 66 215 78 241 25 50 112 150 86 230 22 42 145 12 207 206 29 139 98 222 146 79 29 151 111 158 61 33 106 190 35 50 17 16 80 59 S01H044631 S01H055478 METRA01139 4.5161E+15 62 70 228 376 77 8 76 59 88 48 205 161 155 11 204 37 4 12 233 30 189 92 9 232 221 30 411 31 14 15 228 163 201 155 91 55 69 44 47 200 205 171 48 40 213 209 19 218 95 96 18 123 266 34 URF.213 CV.793 90 212 URF.173 171 217 URF.175 87 88 110 181 175 72 163 140 121 174 9 43 114 115 160 23 71 141 28 16 202 209 50 14 144 36 141 156 45 708032/14 193 224 72 164 93 98 25 105 57 110 216 138 24 28 74 35 211 185 108 160 192 189 118 43 44 157 154 41 218 153 33 48 219 8 104 53 68 129 75 221 177 146 116 68 38 64 196 7 49 63 37 24 181 10 63 125 251 180 164 240 135 21 340 343 183 01H042957/78 84267 8 26 125 193 17 125 170 210 54 1 161 113 60 90 132 36 24 81 22 23 208 6 131 27 135 42 88 5 226 6 150 156 73 483 183 731000268 246 133 621009 214 83 01H034592 84 01H044355 192 49 149 169 92 93 91 424 62 201 250 61 251 191 195 365 100 227 236 217 97 99 101 102 229 219 103 44 226 46 173 72 129 71 89 95 215 148 140 2 36 20 80 237 32 172 5 39 51 12 94 176 212 179 31 2 25 96 154 30 51 100 43 63 4 255 182 252 256 109 157 85 196 164 200 170 227 234 173 83 19 132 159 21 116 49 21 53 165 13 120 159 11 41 137 62 10 116 106 56 118 55 7 3 8 366 106 114 108 213 268 293 119 14 167 169 168 115 107 54 31 97 112 188
Other Recalls from Philips North America, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0926-2022 | Class II | The IFU for the Autoclavable Temperature Probes... | Feb 7, 2022 |
| Z-1326-2021 | Class II | Philips SureSigns VM4, VM6 and VM8 - Product Us... | Mar 23, 2021 |
| Z-0852-2021 | Class II | Emission Computed Tomography System Image Proce... | Nov 19, 2020 |
| Z-0284-2021 | Class II | Philips Sterilizable Defibrillator Paddles, Swi... | Sep 14, 2020 |
| Z-0285-2021 | Class II | Philips Sterilizable Defibrillator Paddles, Swi... | Sep 14, 2020 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.