Philips GoSafe Mobile Help Button
Medical device recall Z-0004-2016. Published in FDA’s Enforcement Report on Oct 7, 2015.
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 Oct 7, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 34 states named
- 8,616 devices 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?
Irregular battery disconnection resulted in issues with Mobile Health Button (MHB) Charging.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Philips GoSafe Mobile Help Button; 7000MHB. Personal Emergency Response System.
8,616 devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 1030000887 1030000931 1030000934 1030000993 1030001039 1030001057 1030001059 1030001173 1030001182 1030001210 1030001226 1030001254 1030001292 1030001315 1030001318 1030001358 1030001371 1030001441 1030001460 1030001526…
Every code shown here, 1,996 characters
Serial Numbers: 1030000887 1030000931 1030000934 1030000993 1030001039 1030001057 1030001059 1030001173 1030001182 1030001210 1030001226 1030001254 1030001292 1030001315 1030001318 1030001358 1030001371 1030001441 1030001460 1030001526 1030001528 1030001568 1030001640 1030001641 1030001710 1030001720 1030001743 1030001797 1030001807 1030001819 1030002013 1030002025 1030002051 1030002129 1030002185 1030002214 1030002225 1030002233 1030002252 1030002316 1030002331 1030002406 1030002413 1030002444 1030002458 1030002489 1030002524 1030002534 1030002582 1030002601 1030002622 1030002626 1030002638 1030002669 1030002673 1030002689 1030002690 1030002715 1030002736 1030002755 1030002764 1030002881 1030002886 1030002889 1030002890 1030002904 1030002905 1030002924 1030002942 1030002946 1030002947 1030002969 1030002975 1030003005 1030003013 1030003015 1030003044 1030003077 1030003098 1030003143 1030003186 1030003284 1030003308 1030003314 1030003316 1030003392 1030003413 1030003423 1030003428 1030003435 1030003454 1030003457 1030003494 1030003535 1030003560 1030003562 1030003584 1030003650 1030003675 1030003732 1030003734 1030003755 1030003792 1030003804 1030003807 1030003817 1030003856 1030003858 1030003859 1030003861 1030003862 1030003880 1030003951 1030003959 1030003983 1030003985 1030003987 1030003988 1030003994 1030004012 1030004014 1030004018 1030004025 1030004027 1030004071 1030004072 1030004085 1030004091 1030004108 1030004113 1030004118 1030004126 1030004127 1030004134 1030004138 1030004185 1030004203 1030004205 1030004223 1030004225 1030004236 1030004242 1030004250 1030004256 1030004262 1030004270 1030004276 1030004278 1030004292 1030004293 1030004294 1030004297 1030004300 1030004310 1030004311 1030004326 1030004327 1030004339 1030004343 1030004351 1030004385 1030004387 1030004403 1030004413 1030004415 1030004418 1030004424 1030004425 1030004428 1030004430 1030004436 1030004441 1030004444 1030004456 1030004457 1030004463 1030004474 1030004480 1030004481 1030004484…
FDA’s list runs to 8,502 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.
Nationwide Distribution -- AK, AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, MA, MD, MI, MN, MT, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TX, UT, VA, VT, WA, and WI.
The states and territories these words name
34 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Florida
- Georgia
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Montana
- North Carolina
- Nebraska
- New Jersey
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- South Carolina
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
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.
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 Jul 23, 2015.
- FDA classified it on Oct 1, 2015.
- FDA’s Enforcement Report published it on Oct 7, 2015.
- FDA terminated it on Nov 10, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Lifeline Systems, Incorporated, of Framingham, MA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Telephone.
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 8,502 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
-
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.