Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 712055, 712057,…
Medical device recall Z-1448-2013. 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
- 101 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. Records shows table height measurements out of specification with the consequence of potential system mis-alignment.
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
101 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial numbers: 316235 335517 321739 334582 359767 357879 344896 351321 356953 365640 365639 359449 363674 375601/SN0802006 368428 7272440 372848 373508 375366 396836/SN0802372 382140/SN0702475 381883/SN0802010 393931/SN0802399…
Every code shown here, 1,569 characters
Serial numbers: 316235 335517 321739 334582 359767 357879 344896 351321 356953 365640 365639 359449 363674 375601/SN0802006 368428 7272440 372848 373508 375366 396836/SN0802372 382140/SN0702475 381883/SN0802010 393931/SN0802399 396572/SN0802281 392502/SN0802179 390113/SN0802451 386784/SN0802264 381098/SN0802124 390098/SN0802242 382018/SN0802118 9000529 373499/SN0802249 383639/SN0802099 390129/SN0802521 404296/SN0802460 404298/SN0802474 416255/SN0902004 802119 409788/SN0802635 406492/SN0802489 390393/SN0802337 399024/SN0802562 402837/SN0802410 408716/SN0802551 408239/SN0802583 408240/SN0802630 408236/SN0802554 406024/SN0802481 408591 406156/SN0802537 406140/SN0802479 407675/SN0802517 408967/SN0802547 414087/SN08000100 435757/SN09000361 422092/SN0902023 415783/SN0802662 422536/SN09000199 416904/SN08000052 421962/SN09000054 429129/SN09000365 426287/SN09000096 430908/SN09000165 441638/SN09000356 456404/SN10000212 435210/SN0902204 435924/SN09000281 438069/SN09000278 439920/SN09000329 443660/SN10000010 449005/SN10000094 443235/SN09000450 448008/SN10000043 455848/SN10000351 455621/SN10000163 455622/SN10000164 449232/SN10000248 449364/SN10000078 449365/SN10000110 451680/SN10000202 457265/SN10000417 475767/SN11000387 453200/SN10000133 452170/SN10000401 453201/SN10000124 466031/SN11000053 459498/SN10000231 464880/SN10000714 464350/SN10000589 470908/SN11000183 485692/SN11000443 470803/SN10000667 475846/SN11000269 477673/SN11000278 478112/SN11000163 478232/SN11000216 480052/SN11000286 480053/SN11000288 487808/SN11000526 488714/SN11000572 492704/SN11000641
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.”
- 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.