Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 712055, 712057,…
Medical device recall Z-1447-2013. Published in FDA’s Enforcement Report on Jun 26, 2013.
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 Jun 26, 2013. 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
- 177 units 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?
Installation Acceptance Test Document (IATD) non compliant with regulations IATDs (Installation Acceptance Test could not be located or different templates have been used
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 712055, 712057, 712062 Product Usage: Universal RAD Applications
177 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 248244 351896 304009 347726 340184 353318 316236 357275 356983 325939 325940 602603 702009 348997 362251 356153 356131 351083 356334 355648 355646 354256 355644 356526 362438 7212356 359439 357888 355621 370816 357413…
Every code shown here, 1,995 characters
Serial Numbers: 248244 351896 304009 347726 340184 353318 316236 357275 356983 325939 325940 602603 702009 348997 362251 356153 356131 351083 356334 355648 355646 354256 355644 356526 362438 7212356 359439 357888 355621 370816 357413 367356 358322 363680 358494 7000281 363670 703465 363671 367771 375952 365956 372485 372486 369545 70700 372973 374374 375370 380750/SN0702498 385560/SN0802190 401126/SN0802540 396834/SN0802370 414494/SN0802648 429753/SN0902090 434680/SN0902161 379200/SN0802088 390276/SN0802289 390109/SN0802396 383893/SN0802238 419661/SN0902011 402570/SN0802420 425721/SN0902102 414495/SN0802649 381879/SN0802058 384511/SN0802050 384779/SN0802164 410916/SN0802636 392486/SN0802181 434675/SN1002002 427612/SN0902122 389101/SN0802194 384033/SN0802219 392505/SN0802162 392504/SN0802182 382164/SN0802018 367618 396576/SN0802233 427616/SN0902145 428232/SN0902049 415314/SN0902058 396197/SN0802210 445433/SN09000434 398178/SN0802348 427504/SN0902048 399555/SN0802572 422534/SN0902027 399153/SN0802347 422101/SN0902030 412482/SN0802683 404166/SN0802441 402844/SN0802432 402853/SN0902012 405687/SN0802469 404164/SN0802462 404459/SN0802468 407425/SN08000031 418438/SN08000110 409702/SN0802557 435537/SN0902144 408200/SN0802520 409461 414931/SN0902033 412678/SN0802695 410040/SN08000021 410038/SN08000091 410039/SN08000093 423259/SN09000074 422832/SN09000061 412921/SN0802657 427610/SN0902108 433651/SN0902114 413845/SN09000004 415626/SN08000067 416651/SN08000086 422535/SN09020032 437764/SN09000292 421977/SN09000115 455753/SN10000432 455225/SN11000051 423037/SN09000153 421032/SN09000063 421034/SN09000041 427226/SN09000209 428241/SN09000220 435420/SN09000263 441921/SN09000431 440260/SN09000350 430355/SN09000214 441778/SN09000452 440249/SN09000347 439032/SN09000305 440692/SN09000443 444627/SN10000142 442306/SN10000177 442310/SN10000149 442129/SN10000171 442235/SN10000160 455550/SN10000364 461799/SN10000347 446047/SN09000440 449718/SN10000093 446665/SN09000451 461979/SN10000701…
FDA’s list runs to 2,552 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.
Worldwide Distribution - USA Nationwide and the country of Canada
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 Jan 16, 2013.
- FDA classified it on Jun 17, 2013.
- FDA’s Enforcement Report published it on Jun 26, 2013.
- FDA terminated it on Sep 30, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Philips Healthcare Inc., 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 2,552 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.