FDA Device recall Z-1052-2019
MultiDiagnost-Eleva, Product codes 708032, 708036 Product Usage: As a multifunctional I universal imaging application system, General RIF,…
- FDA Device
- Class II
- terminated
- Published 2019-04-03
On 2019-04-03 the FDA classified a Class II recall of MultiDiagnost-Eleva, Product codes 708032, 708036 Product Usage: As a multifunctional I universal imaging application system, General RIF,… by Philips North America, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1052-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-02-28 |
| Published | 2019-04-03 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Philips North America |
| Distribution | US |
Product
MultiDiagnost-Eleva, Product codes 708032, 708036 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.
Reason
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.
Identifiers
| code_info | 4 5 7 8 9 10 11 11 12 12 13 13 14 14 14 15 16 16 17 18 18 19 20 21 21 24 24 25 25 26 26…4 5 7 8 9 10 11 11 12 12 13 13 14 14 14 15 16 16 17 18 18 19 20 21 21 24 24 25 25 26 26 27 28 29 29 29 30 31 31 32 32 33 34 34 35 35 36 36 37 37 38 39 40 40 41 41 42 42 43 43 44 45 46 47 47 48 48 49 49 50 51 52 53 54 55 56 57 59 61 62 67 68 71 72 73 74 75 76 77 81 83 84 84 85 86 87 88 89 90 91 92 93 98 102 103 104 105 106 107 108 109 110 112 113 114 116 118 119 120 121 122 123 123 124 125 126 127 128 129 130 132 133 135 136 137 138 139 140 142 143 145 151 153 154 157 159 160 161 162 163 164 165 166 169 170 171 172 173 174 178 180 181 182 183 184 188 189 190 193 194 196 197 198 199 201 203 205 206 207 208 209 210 211 212 213 214 215 216 217 218 219 220 221 222 224 225 226 227 228 229 231 232 233 235 238 239 240 241 243 244 245 246 247 248 249 251 253 254 255 256 257 258 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1052-2019%22
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