DigitalDiagnost Dual Detector (Stitching Patient Support) 712022
Medical device recall Z-2859-2018. Published in FDA’s Enforcement Report on Aug 29, 2018.
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 Aug 29, 2018. Copied from openFDA on Oct 20, 2026.
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 hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
DigitalDiagnost Dual Detector (Stitching Patient Support) 712022
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 488713/SN11000577 488714/SN11000572 444623/SN10000136 480503/SN11000473 480504/SN11000478 410040/SN08000021 422832/SN09000061 462407/SN10000363 448130/SN10000008 464981/SN10000471 455752/SN10000200 454061/SN10000216…
Every code shown here, 1,440 characters
Serial Numbers: 488713/SN11000577 488714/SN11000572 444623/SN10000136 480503/SN11000473 480504/SN11000478 410040/SN08000021 422832/SN09000061 462407/SN10000363 448130/SN10000008 464981/SN10000471 455752/SN10000200 454061/SN10000216 426292/SN09000386 455546/SN10000143 420090/SN09000018 474817/SN11000080 474238/SN11000042 461799/SN10000347 455621/SN10000163 471148/SN11000122 471147/SN11000120 482904/SN11000375 482905/SN11000373 482903/SN11000379 440249/SN09000347 481021/SN11000446 487808/SN11000526 441778/SN09000452 432989/SN09000285 478307/SN12000004 476338/SN12000026 476034/SN12000027 422536/SN09000199 486638/SN11000494 466808/SN10000464 462593/SN10000439 471150/SN10000660 478233/SN11000233 473897/SN11000165 482501/SN11000527 453200/SN10000133 456093/SN10000204 461979/SN10000701 461976/SN10000704 443093/SN09000454 445110/SN09000461 16750755 477524/SN11000434 475932/SN11000341 475866/SN11000350 451542/SN10000098 442534/SN09000423 443443/SN09000420 484558/SN11000525 479928/SN11000287 466029/SN10000420 472613/SN11000162 480061/SN11000474 453085/SN10000125 467927/SN10000713 450779/SN10000062 480881/SN11000274 476835/SN11000179 442005/SN10000298 444627/SN10000142 442310/SN10000149 478181/SN11000455 481142/SN11000318 467348/SN11000207 441637/SN09000354 441638/SN09000356 464863/SN10000533 464880/SN10000714 421977/SN09000115 449365/SN10000110 464755/SN10000391 430355/SN09000214 451543/SN10000100 ***Added 5/6/21*** SN15000449
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; International to 66 countries
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 Jun 27, 2018.
- FDA classified it on Aug 17, 2018.
- FDA’s Enforcement Report published it on Aug 29, 2018.
- FDA terminated it on Apr 30, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Philips Medical Systems Gmbh, DMC, of Hamburg, Germany.
- 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.