The ORCHESTRA PLUS Programmer A portable device, equipped with a microprocessor used to program and…
Medical device recall Z-0413-2017. Published in FDA’s Enforcement Report on Nov 23, 2016.
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 Nov 23, 2016. 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
- 586 programmers 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?
Sorin Group USA, Inc. announces a voluntary field action for the ORCHESTRA Programmer and ORCHESTRA PLUS Programmer because the residual longevity estimate may be less accurate.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
The ORCHESTRA PLUS Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemakers and defibrillators. The programmer also provides measurement, ECG display and report printing functions that are essential for monitoring implant patients.
586 programmers, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: NB1006418K NB1107409K NB1203456K NB1107407K NB1105419K NB0908405K NB1202447K NA0804365K NB1201447K NA0807425K NB0909407K NB1112470K NB0909402K NB1112474K NB1112444K NB1201403K NB1201402K NB1102423K NB1112471K NA0804393K…
Every code shown here, 1,996 characters
Serial Numbers: NB1006418K NB1107409K NB1203456K NB1107407K NB1105419K NB0908405K NB1202447K NA0804365K NB1201447K NA0807425K NB0909407K NB1112470K NB0909402K NB1112474K NB1112444K NB1201403K NB1201402K NB1102423K NB1112471K NA0804393K NB1203431K NA0804389K NB1004403K NB1202418K NB1108403K NB1007410K NB1105438K NA0804367K NB1102406K NA0804384K NB1202458K NA0804321K NB1006415K NB1201455K NB1102402K NB1107417K NB1109421K NB1202454K NC1503413K NA0804353K NB1112482K NB1108404K NB1105436K NB0907430K NB1112485K NA0804343K NB1109418K NB1104409K NB1112414K NB0908415K NB1112407K NB1108425K NB1006402K NB1203428K NA0804426K NA0804390K NB0911402K NB0907419K NB0909417K NB1203415K NB1201442K NA0804363K NB0911414K NB0908411K NB0910412K NA0807414K NA0804387K NB1102405K NB1201409K NB1201423K NB1004416K NB1108401K NB1002406K NB1203429K NB0907433K NB1202474K NB1103415K NB1112427K NB1202462K NB1202469K NA0804319K NB1102425K NA0804339K NB1003402K NB1102404K NB0909410K NB0911404K NB1108429K NB1203444K NB1203423K NB1201434K NA0804410K NB0909430K NB1202413K NB1201454K NB1001405K NA0904419K NA0902423K NB0907425K NB1202435K NB1203417K NA0904415K NB0907413K NB1105401K NB1112455K NA0904413K NB1112423K NB1201410K NB1112404K NA0904414K NB1108428K NB1112454K NB0911401K NB1007406K NB1102428K NB1201450K NB1001409K NB1112463K NA0804433K NB1105404K NB1202423K NB1201430K NB1203453K NB1006410K NC1503412K NA0804373K NA0804378K NB1201449K NA0804358K NB1108412K NB1201406K NB0907410K NB1006403K NA0804362K NB1004406K NB0908414K NA0902406K NA0804432K NB1002401K NB0909405K NA0807429K NB0911415K NA0804313K NB1109402K NB1203454K NB1202409K NB1202453K NB1201440K NB0905015K NB1202464K NB1202442K NA0804340K NB1201439K NB1109412K NB1102407K NB1112410K NB1108418K NB1104416K NB0907414K NB1202424K NB1201445K NB1201452K NB0907417K NB1202432K NA0804411K NB1202408K NB1007402K NB1103409K NB1112459K NB1202430K NA0804383K NB1108426K NB1010412K NB0911412K NB1202440K NB1102429K NB1104405K NB1203409K NB1010408K NB1109417K…
FDA’s list runs to 19,353 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.
Programmers were distributed nationwide, to VA/govt/military, Canadian, and other foreign consignees.
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 Sep 29, 2016.
- FDA classified it on Nov 15, 2016.
- FDA’s Enforcement Report published it on Nov 23, 2016.
- FDA terminated it on May 15, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Sorin Group USA, Inc., of Arvada, CO.
- 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 19,353 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.