The ORCHESTRA Programmer A portable device, equipped with a microprocessor used to program and interrogate…
Medical device recall Z-0412-2017. 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
- 847 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 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.
847 programmers, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: BB0011103G BC0206105G BC0408064G BB0011111G BD0505094I BC0405016G BB0102071G BC0206096G BD0507033I BD0505110I BD0507019I BC0206076G BE0611036I BB0203034G BB0011099G BB0103048G BC0408067G BD0509044I BB0012010G BD0501100G…
Every code shown here, 1,996 characters
Serial Numbers: BB0011103G BC0206105G BC0408064G BB0011111G BD0505094I BC0405016G BB0102071G BC0206096G BD0507033I BD0505110I BD0507019I BC0206076G BE0611036I BB0203034G BB0011099G BB0103048G BC0408067G BD0509044I BB0012010G BD0501100G BC0206131G BD0501096G BA0006167G BB0011169G BD0510018I BD0505029I BD0505039I BB0102074G BD0507014I BB0101021G BD0506112I BA0007003G BB0010078G BB0010213G BC0206089G BC0205079G BD0501099G BA0004162G BB0011101G BD0501094G BB0103027G BB0012068G BD0507005I BB0011003G BB0011086G BC0408057G BB0012075G BA0005050G BC0303071G BD0507060I BB0010268G BB0012154G BC0303073G BA0006171G BB0011080G BC0312045G BC0206144G BD0505016I BC0206029G BB0012184G BD0505018I BC0405050G BD0501085G BD0506136I BB0011083G BB0012056G BE0611013I BD0507053I BD0505028I BC0408078G BE0603002I BE0603012I BB0011166G BB0012150G BB0012067G BB0012171G BB0011020G BC0212074G BB0010250G BD0507025I BB0203012G BD0501061G BC0206110G BE0611023I BB0011141G BD0502041G BE0611087I BB0012017G BB0010193G BC0205082G BD0509048I BA0006178G BB0010252G BB0101092G BB0012182G BC0405037G BD0505001I BD0507065I BC0405022G BB0203059G BD0505097I BD0502013G BB0012125G BD0506123I BD0501074G BB0102069G BC0405024G BB0012151G BB0012183G BB0203052G BD0505061I BE0611062I BC0212076G BD0510028I BB0010063G BB0012019G BB0203028G BB0012062G BB0010057G BC0212080G BE0603018I BC0312059G BE0611082I BC0405025G BC0206067G BB0010273G BB0102068G BB0011032G BB0010080G BB0010271G BA0005233G BD0506111I BD0502035G BD0509046I BC0206138G BD0505002I BB0012166G BC0408072G BD0506106I BE0611041I BE0611043I BA0004161G BB0011037G BB0203037G BD0505045I BD0505052I BD0505008I BB0010294G BB0011042G BB0012070G BD0501118G BD0501116G BE0611008I BC0212068G BC0212083G BD0501109G BB0012027G BB0010207G BC0212085G BC0212086G BD0501087G BB0203050G BB0010291G BC0212079G BE0611022I BE0611009I BB0012060G BD0510024I BD0505068I BD0510022I BD0506125I BC0212048G BD0505090I BB0102059G BC0312055G BC0206146G BC0206073G BD0506124I BC0303082G BB0102075G…
FDA’s list runs to 28,062 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 28,062 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.