Hearth Record

Arial 900 MHz Call Station

Medical device recall Z-1031-2026. Published in FDA’s Enforcement Report on Jan 14, 2026.

FDA’s own record, on accessdata.fda.gov

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 Jan 14, 2026. 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.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

What’s wrong with it?

Securitas Healthcare has become aware of a firmware issue in the Call Stations in the Affected Lots that may cause Call Stations in the Affected Lots to (1) not transmit a low battery alert to the Arial Wireless Emergency Call System prior to battery failure, or (2) not transmit a low battery alert to the Arial Wireless Emergency Call system at least seven (7) days prior to the battery failing.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Which ones are recalled?

Arial 900 MHz Call Station, Model Number CSK200-900, with Firmware version: 1.6.3

5627 units, in FDA’s words.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Codes to check against yours

All units of the Affected Device Models sold between January 1st, 2023 and June 26th, 2024. UDI-DI: 00840948102653; Serial Numbers: 000CCC0E68FE 000CCC0E6901 000CCC0E6907 000CCC0E68FF 000CCC0E6638 000CCC0E6905 000CCC0E68FD 000CCC0E6904…

Every code shown here, 1,991 characters

All units of the Affected Device Models sold between January 1st, 2023 and June 26th, 2024. UDI-DI: 00840948102653; Serial Numbers: 000CCC0E68FE 000CCC0E6901 000CCC0E6907 000CCC0E68FF 000CCC0E6638 000CCC0E6905 000CCC0E68FD 000CCC0E6904 000CCC0E6908 000CCC0E69AD 000CCC0E6902 000CCC0E69AE 000CCC0E69A9 000CCC0E69A8 000CCC0E6639 000CCC0E6903 000CCC0E69AA 000CCC0E6900 000CCC0E69A6 000CCC0E6B16 000CCC0E6B0D 000CCC0E6B12 000CCC0E6B20 000CCC0E6B10 000CCC0E6B1C 000CCC0E6B21 000CCC0E6B14 000CCC0E6B0C 000CCC0E6B1A 000CCC0E6B11 000CCC0E6B1F 000CCC0E6B22 000CCC0E6B15 000CCC0E6B0E 000CCC0E6B0F 000CCC0E69A5 000CCC0E69AC 000CCC0E69A3 000CCC0E69AB 000CCC0E69A4 000CCC0E6B17 000CCC0E6B19 000CCC0E6B0B 000CCC0E6B1E 000CCC0E6B13 000CCC0E6B18 000CCC0E6B1D 000CCC0E6B1B 000CCC0E6ACA 000CCC0E6ACB 000CCC0E6ABF 000CCC0E6AC4 000CCC0E6AAF 000CCC0E6ABB 000CCC0E6AB8 000CCC0E6ABD 000CCC0E6AB7 000CCC0E6ABE 000CCC0E6AC2 000CCC0E6ABA 000CCC0E6A5D 000CCC0E6A74 000CCC0E6A61 000CCC0E6A57 000CCC0E6A58 000CCC0E6A5C 000CCC0E6A62 000CCC0E6A79 000CCC0E6A6F 000CCC0E6A5B 000CCC0E6A5E 000CCC0E6A59 000CCC0E6A78 000CCC0E6B2C 000CCC0E6B26 000CCC0E6B24 000CCC0E6B35 000CCC0E6B3A 000CCC0E6B28 000CCC0E6B2E 000CCC0E6B29 000CCC0E6B31 000CCC0E6B23 000CCC0E6B2A 000CCC0E6B34 000CCC0E6B38 000CCC0E6B36 000CCC0E6B27 000CCC0E6B33 000CCC0E6B39 000CCC0E6B25 000CCC0E6B2D 000CCC0E6B2B 000CCC0E6B32 000CCC0E6B2F 000CCC0E6B37 000CCC0E6B30 000CCC0E6A6C 000CCC0E6A6B 000CCC0E6948 000CCC0E6A67 000CCC0E6637 000CCC0E6946 000CCC0E6945 000CCC0E6947 000CCC0E6A68 000CCC0E6636 000CCC0E6A66 000CCC0E694D 000CCC0E6949 000CCC0E6A63 000CCC0E694F 000CCC0E694B 000CCC0E6A6D 000CCC0E6A69 000CCC0E694C 000CCC0E6A65 000CCC0E6A6A 000CCC0E6950 000CCC0E6A6E 000CCC0E694A 000CCC0E6A1E 000CCC0E6A50 000CCC0E6A24 000CCC0E6A4F 000CCC0E6A1F 000CCC0E6AD2 000CCC0E6A25 000CCC0E6A4C 000CCC0E6AD4 000CCC0E6AD7 000CCC0E6AC6 000CCC0E6ACD 000CCC0E6AC3 000CCC0E6ACE 000CCC0E6AC8 000CCC0E6AD9 000CCC0E6ADA 000CCC0E6AD0 000CCC0E6AD5 000CCC0E6AD8 000CCC0E6ACC 000CCC0E6AC7…

FDA’s list runs to 73,286 characters. The first part is shown; the rest is on FDA’s record.

Source:

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.

Worldwide distribution -US Nationwide and the country of Canada.

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.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

Is it still going on?

Ongoing, in FDA’s file.

“A recall which is currently in progress.”

openFDA, on “On-Going”, its enforcement report fields.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

  • The firm began the recall on Dec 8, 2025.
  • FDA classified it on Jan 8, 2026.
  • FDA’s Enforcement Report published it on Jan 14, 2026.
Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Who is recalling it?

  • Securitas Healthcare LLC, of Lincoln, NE.
  • Who began it, in FDA’s words: Voluntary: Firm initiated.
  • How the firm first told its customers: Letter.
Source:

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 73,286 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.
Source:

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.

Source:

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.

How to read a record

Four things every record does, shown on an example record made up for this guide.

An example record, made up for this guide

An example nursing home

Made up for this guide: no real place is shown

Not fully inspected in over two years (CMS flag)

11 health citations at the latest inspection cycle

The state average is 14.3.

Source:

CMS, State and US Averages and Health Deficiencies. Released Oct 28, 2026. Updated monthly.

From the homeNone yet. Replies and paid listings aren’t open, and when they open they will sit here, below the record.

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Every fact names its source.

Who published it, when, and how often it changes sit beside each fact, with a link to the agency’s own file.

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