MultiDiagnost Eleva w/ Flat Detector
Medical device recall Z-1055-2019. Published in FDA’s Enforcement Report on Apr 3, 2019.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Apr 3, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 1969 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
1969, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,998 characters
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…
FDA’s list runs to 2,215 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US Nationwide domestic distribution, and worldwide international distribution.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Feb 28, 2019.
- FDA classified it on Mar 23, 2019.
- FDA’s Enforcement Report published it on Apr 3, 2019.
- FDA terminated it on Aug 3, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Philips North America, LLC, of Andover, MA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 2,215 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.