Reported Apr 3, 2019 · Terminated

Omnidiagnost Classic, Product Codes 70859, 708023, 708024, 708025 Product Usage: The Philips OmniDiagnost is a…

Philips North America, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Philips North America, LLC · 3000 Minuteman Rd · Andover, MA · 01810-1032

Is this the product you have?

    • Omnidiagnost Classic
    • Product Codes 70859
    • 708023
    • 708024
    • 708025
  • Product UsageThe 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 includeGastro-intestinal examination Urography Bronchography Arthrography Hysterography Myelography Lymphography Skeletal radiography Tomography Venography/phlebography Special procedures that require subtracted and
  • non-subtracted digital imagingincludeAngiography Peripheral angiography (bolus chasing) Vascular and non-vascular interventional procedures
Lot codes and dates

4 of 4 products

Products covered by this recall
Model / numberBarcodesProduct as published
4163250111708023019087970478028909_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
4665620/35547001800003264831320/480 60 609 66 68
7080230154537080230159957080230181937080231896 70802322
708023510671037602594478 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
Amount recalled
1696

This recall covers 6 products

The agency filed one notice per product. You are reading one of them; the other 5 are below.

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 3, 2020 · Data as of Sep 19, 6:18 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.