DigitalDiagnost Release 3 (Stitching Patient Support) 712025
Medical device recall Z-2861-2018. 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 Release 3 (Stitching Patient Support) 712025
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: SN13000132 514201/SN12000334 SN13000145 485094/SN11000028 485093/SN11000029 SN13000150 498131/SN12000072 515567/SN12000365 SN13000186 SN13000227 SN13000280 514978/SN12000374 514917/SN12000338 520248/SN13000057…
Every code shown here, 1,428 characters
Serial Numbers: SN13000132 514201/SN12000334 SN13000145 485094/SN11000028 485093/SN11000029 SN13000150 498131/SN12000072 515567/SN12000365 SN13000186 SN13000227 SN13000280 514978/SN12000374 514917/SN12000338 520248/SN13000057 512305/SN12000296 499378/SN12000065 515647/SN12000361 SN13000162 SN13000322 SN13000388 SN13000440 518940/SN13000015 498389/SN12000046 SN13000419 SN13000183 497871/SN12000116 497872/SN12000123 SN13000170 493886/SN12000067 SN13000247 521377/SN13000113 512184/SN12000267 514540/SN12000384 514291/SN12000322 506687/SN12000184 506685/SN12000185 515888/SN12000342 515889/SN12000357 519026/SN13000028 514210/SN12000313 505513/SN12000302 519509/SN13000056 492928 515713/SN13000093 SN13000426 513549/SN12000332 504226/SN12000212 513792/SN12000295 SN13000260 514303/SN12000395 494356/SN12000005 515262/SN12000324 SN13000311 SN13000111 496399/SN12000118 496394/SN12000045 497058/SN12000030 518706/SN13000045 506258/SN12000152 519609/SN13000060 512167/SN13000097 SN13000342 504404/SN12000223 519329/SN13000044 SN13000265 192929/SN11000055 SN13000447 SN13000366 SN13000456 504665/SN12000213 521255/SN13000104 491790/SN11000073 495027/SN12000034 517758/SN12000389 SN13000341 SN13000314 504769/SN12000214 488603/SN11000063 489349/SN11000067 514290/SN13000013 512235/SN12000289 SN13000176 515464/SN12000327 491708/SN12000001 497889/SN12000106 492192/SN12000028 SN13000336 SN13000143 499759/SN12000080 503540/SN12000197
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.