Omnidiagnost Classic
Medical device recall Z-1054-2019. 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
- 1696 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?
Omnidiagnost Classic, Product Codes 70859, 708023, 708024, 708025 Product Usage: The Philips OmniDiagnost is a multi-functional, universal X-ray system with remote-controlled facilities. It performs a wide range of routine examinations and interventional procedures include: Gastro-intestinal examination Urography Bronchography Arthrography Hysterography Myelography Lymphography Skeletal radiography Tomography Venography/phlebography Special procedures that require subtracted and non-subtracted digital imaginginclude: Angiography Peripheral angiography (bolus chasing) Vascular and non-vascular interventional procedures.
1696, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial numbers 1 2 3 4 7 9 10 11 12 13 14 15 16 17 18 19 20 22 23 24 25 26 27 28 29 30 31 32 33 34 36 38 39 41 42 44 46 47 48 49 50 51 52 53 54 56 58 60 61 62 64 65 66 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 94…
Every code shown here, 1,873 characters
Serial numbers 1 2 3 4 7 9 10 11 12 13 14 15 16 17 18 19 20 22 23 24 25 26 27 28 29 30 31 32 33 34 36 38 39 41 42 44 46 47 48 49 50 51 52 53 54 56 58 60 61 62 64 65 66 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 94 95 96 97 98 101 102 103 104 104 106 107 108 109 110 111 111 112 113 115 116 117 118 118 119 120 121 123 123 124 126 127 128 129 130 131 132 133 134 135 135 136 137 138 139 140 142 143 145 146 146 147 148 149 150 151 152 153 154 156 157 158 159 161 164 165 167 173 183 195 198 199 216 217 227 251 253 259 274 281 286 297 317 323 327 333 336 340 348 353 353 358 369 378 380 390 391 393 402 421 423 426 428 438 441 466 471 473 474 481 486 498 504 514 520 530 570 574 592 598 608 664 1489 1529 3019 13124 38351 50428 76596 76948 82655 83871 83958 85163 86113 86303 86326 9341573 41355410 4163250111 708023019087 970478028909 _000364 _073 _082 _146 _302 _332 _345 _364 _371 ~~~~~~~~~~1 ~~~1 096B 1 1*015 112 11591 12 122 1232 126% 131 13310 136 14*009-Omni 141% 163 175 175 178 182 185 190 201 202 210 221 224 225 237 248 26 266 268 275 280 282 284 294 306 319 324 3243 326 3278012607 339 355 365 370 3797350-9 381 389 392 3A57204 401 4042910/000134 407 411 413554106 416 4188010/0171 419 4349690/000217 436 447 463 4665620/000374 4665620/355 4700180000326 4831320/480 60 609 66 68 708023015453 708023015995 708023018193 7080231896 70802322 7080235106 710376025944 78 8 83 84850 86549 86965 86977 87% 87164 89 90 96 97 98 99 C@20236 C@20238 C@20239 C@20241 C@20286 C@21319 C@21325 C@21338 C@21339 C@21353 C@21388 C@21389 C@21390 C@21398 C@21402 C@21406 C@21414 C@22528 C@22599 C@226 C@98168 C@99218 C@99224 GEN023210 GEN023233 M16331 M17264 M19163 M19164 M19169 M19269 M20825 M21186 M22124 S100000980/000001 S100002676/000001 S100002705/000001 S103815/1 S1048831 S3F000861A/117337 S3F000862A/117338 SN98170 URF.092 URF.130 URF.186 URF.218
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.”
- 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.