Philips BuckyDiagnost Radiographic
Medical device recall Z-1450-2013. 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
- 116 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?
An inspection of IATD (Installation Acceptance Test Document)IA SID (Source Image Distance) 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 BuckyDiagnost Radiographic. Catalog Numbers: 704031, 704032, 704035, 704060, 704062 This system is used for making x-ray exposures for diagnostics
116 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 334584 345869 349805 352617 375957/SN07000650 352645 355617 356954 363678 362217 362252 361021 364214 362429 361526 363545 363802 364816 366510 366090 367504 370290 370643 373506 372845 376998 383090 384688/SN07000603…
Every code shown here, 1,799 characters
Serial Numbers: 334584 345869 349805 352617 375957/SN07000650 352645 355617 356954 363678 362217 362252 361021 364214 362429 361526 363545 363802 364816 366510 366090 367504 370290 370643 373506 372845 376998 383090 384688/SN07000603 386397/SN07000659 406161/SN08000556 386265/SN08000415 389969/SN08000090 381103/SN08000131 444254/SN09000380 406491/SN08000315 389383/SN08000100 447038/SN10000169 389970/SN08000092 406017/SN08000307 389972/SN08000080 389656/SN08000052 386679/SN08000051 390255/SN08000050 394368/SN08000196 396406/SN08000193 399529/SN08000297 401268/SN08000268 402249/SN08000323 399571/SN08000559 384510/SN07000618 402246/SN08000261 403330/SN08000296 403648/SN08000292 407890/SN08000377 405887/SN08000381 413307/SN08000521 413205/SN08000562 411311/SN08000528 419318/SN09000042 428504/SN09000200 413818/SN08000526 414461/SN08000518 414601/SN08000501 438511/SN10000166 414315/SN08000474 418205/SN08000568 419316/SN09000007 421970/SN09000058 422097/SN09000068 426137/SN09000109 430918/SN09000175 435194/SN09000234 439546/SN09000334 439739/SN09000346 436337/SN09000251 438835/SN09000295 439098/SN09000294 439817/SN09000318 443072/SN09000363 443231/SN09000368 442855/SN09000357 443453/SN09000378 456506/SN10000167 449719/SN10000034 448152/SN10000013 448150/SN10000072 449717/SN10000068 450554/SN10000096 451156/SN10000059 456283/SN10000272 456082/SN10000174 458580/SN10000196 459495/SN10000212 460074/SN10000260 460485/SN10000228 460757/SN10000290 461677/SN10000302 461229/SN10000218 462389/SN10000252 463385/SN10000344 465974/SN10000320 468064/SN10000347 466164/SN10000336 468078/SN11000032 468518/SN10000353 470291/SN10000374 471046/SN10000386 471701/SN11000054 483054/SN11000246 476276/SN11000045 480210/SN11000126 483867/SN11000298 483244/SN11000199 486144/SN11000217 488176/SN11000244
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 - US 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 Oct 15, 2013.
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
-
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.