Class II U.S. Food and Drug Administration

Securitas Healthcare LLC Arial 900 MHz Call Station recall: Securitas Healthcare has become aware of a firmware issue in the Call

Recall published 9 months ago

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.

The hazard: Device malfunction

This is a device recall, and in FDA language that usually means a correction rather than a removal: the device stays in use and the manufacturer fixes, patches or re-instructs.

What the notice says: 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.

Why it matters: The device may not perform as intended — a mechanical failure, a software defect, an inaccurate reading, or an alarm that does not sound. For a device someone depends on, the consequence of the failure is usually worse than the failure itself.

Symptoms and when to call a doctor

If the device supports a vital function, do not disable or remove it on your own judgement. Contact the clinician who prescribed or fitted it, and use the back-up arrangement they gave you. Go to an emergency department if the symptoms the device is meant to manage are getting worse, or if an implanted device gives an unexpected alarm or shock.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-1031-2026
Published
January 14, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Securitas Healthcare LLC
Product type
Medical devices
Units affected
5627 units
Distribution
Nationwide
Made in
United States
Lot / code info
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 000CCC0E6AD6 000CCC0E6AD3 000CCC0E6AC9 000CCC0E6AC5 000CCC0E6AD1 000CCC0E6ACF 000CCC0E6DCD 000CCC0E6DCE 000CCC0E6DAA 000CCC0E6DAC 000CCC0E6DB4 000CCC0E6DD0 000CCC0E6DAF 000CCC0E6DD6 000CCC0E6DB0 000CCC0E6DA9 000CCC0E6DB2 000CCC0E6DD7 000CCC0E6DB3 000CCC0E6DD1 000CCC0E6DB1 000CCC0E6DD2 000CCC0E6DAD 000CCC0E6DD4 000CCC0E6A4D 000CCC0E6DD5 000CCC0E6DCF 000CCC0E6DAE 000CCC0E6B68 000CCC0E6E27 000CCC81812355 000CCC0E6E2E 000CCC0E6E2A 000CCC0E6E2D 000CCC0E6E36 000CCC0E6E29 000CCC0E6E2F 000CCC0E6CDA 000CCC0E6CD3 000CCC0E6DF5 000CCC0E6B5F 000CCC0E6B66 000CCC0E6B60 000CCC0E6B61 000CCC0E6A64 000CCC0E6CD2 000CCC0E6B64 000CCC0E6B62 000CCC0E6CD1 000CCC0E6CDB 000CCC0E6B63 000CCC0E6CD9 000CCC0E6CD6 000CCC0E6CD5 000CCC0E6CD4 000CCC0E6B67 000CCC0E6B65 000CCC0E6CD8 000CCC0E6CDC 000CCC0E6D80 000CCC0E6D9B 000CCC0E6D93 000CCC0E6D7B 000CCC0E6D82 000CCC0E6D9C 000CCC0E6D98 000CCC0E6D9A 000CCC0E6D81 000CCC0E6D79 000CCC0E6D7A 000CCC0E6D84 000CCC0E6D7E 000CCC0E6D91 000CCC0E6D7C 000CCC0E6D92 000CCC0E6D99 000CCC0E6D7D 000CCC0E6D97 000CCC0E6D95 000CCC0E6D96 000CCC0E6D7F 000CCC0E6D83 000CCC0E6D94 000CCC0E6E26 000CCC0E6E34 000CCC0E6E35 000CCC0E6E38 000CCC0E6E33 000CCC0E6E31 000CCC0E6E3B 000CCC0E6E2B 000CCC0E6E32 000CCC0E6E30 000CCC0E6E2C 000CCC0E6E28 000CCC0E6E39 000CCC0E6E3D 000CCC0E6E3C 000CCC0E6E37 000CCC0E6DAB 000CCC0E6DD8 000CCC0E6DD3 000CCC0E6CD7 000CCC0E6D89 000CCC0E6D8D 000CCC0E6D8E 000CCC0E6D78 000CCC0E6D76 000CCC0E6D90 000CCC0E6D8F 000CCC0E6D75 000CCC0E6D8B 000CCC0E6D74 000CCC0E6D6D 000CCC0E6D71 000CCC0E6D6F 000CCC0E6D85 000CCC0E6D8C 000CCC0E6D87 000CCC0E6D72 000CCC0E6D6E 000CCC0E6D70 000CCC0E6D88 000CCC0E6D86 000CCC0E6D73 000CCC0E6D77 000CCC0E6DB6 000CCC0E6DB9 000CCC0E6D54 000CCC0E6DB5 000CCC0E6D52 000CCC0E6D4B 000CCC0E6D4E 000CCC0E6DB8 000CCC0E6DBD 000CCC0E6DB7 000CCC0E6D4F 000CCC0E6DBE 000CCC0E6D53 000CCC0E6DBF 000CCC0E6D49 000CCC0E6DBA 000CCC0E6DBB 000CCC0E6DC0 000CCC0E6D4D 000CCC0E6DBC 000CCC0E6D50 000CCC0E6D4C 000CCC0E6D4A 000CCC0E6D51 000CCC0E6DA8 000CCC0E6DC7 000CCC0E6DC3 000CCC0E6DA7 000C…
UPC codes
00840948102653

Products covered by this recall

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

Check your product

The notice names 6 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00840948102653

Model or item number

On the rating label, the box or the instruction sheet.

  • CSK200-900
  • 2023
  • June 26th
  • 2024

Serial number

On the rating plate, often next to the date of manufacture.

  • 000CCC0E68FE 000CCC0E6901 000CCC0E6907 00

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Malfunction

Securitas Healthcare LLC — This is a device recall, and in FDA language that usually means a correction rather than a removal: the device stays in use and the manufacturer fixes, patches or re-instructs.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers listed on this page.
  2. Report device problems to the FDA through MedWatch — that database is where this recall came from.
  3. If the device is implanted, or you depend on it daily, speak to your clinician before changing anything about how you use it.
  4. Check whether the remedy is a software update, and if so confirm afterwards in the device menu that the version actually changed.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: Securitas Healthcare LLC — 4600 Vine St, Lincoln, NE, 68503-2823

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Securitas Healthcare LLC medical devices recalled?

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. 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…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00840948102653; model number CSK200-900, 2023, June 26th. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers listed on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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