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

A malfunction was identified in this device. What matters most is whether your particular unit falls inside the affected model, lot or serial range.

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-1032-2026
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
1898 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: 00840948102660; Serial Numbers:000CCC0E6CC9 000CCC0E6CC6 000CCC0E6CCC 000CCC0E6CCE 000CCC0E6CC5 000CCC0E6CD0 000CCC0E6D1F 000CCC0E6D1B 000CCC0E6D24 000CCC0E6D1C 000CCC0E6D22 000CCC0E6D01 000CCC0E6D04 000CCC0E6D19 000CCC0E6D1A 000CCC0E6D1E 000CCC0E6CC8 000CCC0E6D23 000CCC0E6CCD 000CCC0E6D1D 000CCC0E6CCB 000CCC0E6CCA 000CCC0E6CC7 000CCC0E6D20 000CCC0E6CCF 000CCC0E627E 000CCC0E6286 000CCC0E628C 000CCC0E6282 000CCC0E627C 000CCC0E6279 000CCC0E6289 000CCC0E627A 000CCC0E628E 000CCC0E627D 000CCC0E6288 000CCC0E6280 000CCC0E6284 000CCC0E6DDB 000CCC0E6D2E 000CCC0E6D28 000CCC0E6DE0 000CCC0E6D27 000CCC0E6D2C 000CCC0E6D2F 000CCC0E6DE3 000CCC0E6D2D 000CCC0E6D30 000CCC0E6DE1 000CCC0E6DD9 000CCC0E6DDF 000CCC0E6D25 000CCC0E6DDE 000CCC0E6DE4 000CCC0E6D2A 000CCC0E6D2B 000CCC0E6D29 000CCC0E6DDC 000CCC0E6DDA 000CCC0E6D26 000CCC0E6D36 000CCC0E6D32 000CCC0E6D06 000CCC0E6D33 000CCC0E6D3C 000CCC0E6D38 000CCC0E6D3B 000CCC0E6D07 000CCC0E6D05 000CCC0E6D0B 000CCC0E6D0A 000CCC0E6D0C 000CCC0E6D03 000CCC0E6D37 000CCC0E6D31 000CCC0E6D39 000CCC0E6D35 000CCC0E6D3A 000CCC0E6D34 000CCC0E6D08 000CCC0E6341 000CCC0E6D02 000CCC0E6D09 000CCC0E5B9F 000CCC0E5BD5 000CCC0E5BE0 000CCC0E6719 000CCC0E676D 000CCC0E676E 000CCC0E6DE2 000CCC0E6DDD 000CCC0E6CBC 000CCC0E6CC0 000CCC0E6CBF 000CCC0E6CBB 000CCC0E6CB9 000CCC0E6CBA 000CCC0E6D6A 000CCC0E6CC2 000CCC0E6CBE 000CCC0E6D61 000CCC0E6D67 000CCC0E6D68 000CCC0E6D62 000CCC0E6CC1 000CCC0E6D65 000CCC0E6D63 000CCC0E6CC3 000CCC0E6D66 000CCC0E6CBD 000CCC0E6CC4 000CCC0E6D64 000CCC0E6D69 000CCC0E6D6C 000CCC0E6D6B 000CCC0E6483 000CCC0E6482 000CCC0E647D 000CCC0E62A2 000CCC0E6484 000CCC0E633D 000CCC0E647A 000CCC0E647B 000CCC0E6340 000CCC0E6480 000CCC0E6481 000CCC0E647E 000CCC0E633C 000CCC0E62B6 000CCC0E647F 000CCC0E647C 000CCC0E6342 000CCC0E6343 000CCC0E633A 000CCC0E6479 000CCC0E6271 000CCC0E6278 000CCC0E6270 000CCC0E635C 000CCC0E6354 000CCC0E6353 000CCC0E6275 000CCC0E6355 000CCC0E6374 000CCC0E6357 000CCC0E6273 000CCC0E635B 000CCC0E6276 000CCC0E6352 000CCC0E626F 000CCC0E6358 000CCC0E6274 000CCC0E635A 000CCC0E626D 000CCC0E6356 000CCC0E6351 000CCC0E62A0 000CCC0E62A3 000CCC0E62A5 000CCC0E62BD 000CCC0E62C0 000CCC0E629D 000CCC0E62B5 000CCC0E62A1 000CCC0E629F 000CCC0E62B8 000CCC0E62BE 000CCC0E62BB 000CCC0E62A6 000CCC0E62BC 000CCC0E62BA 000CCC0E62A8 000CCC0E62BF 000CCC0E6277 000CCC0E6261 000CCC0E626E 000CCC0E6359 000CCC0E6265 000CCC0E6272 000CCC0E6531 000CCC0E652D 000CCC0E652E 000CCC0E6535 000CCC0E62EF 000CCC0E6537 000CCC0E6532 000CCC0E6530 000CCC0E6536 000CCC0E6538 000CCC0E652F 000CCC0E6533 000CCC0E6534 000CCC0E64E4 000CCC0E64DD 000CCC0E64DB 000CCC0E64DF 000CCC0E64DE 000CCC0E64E1 000CCC0E6329 000CCC0E632A 000CCC0E64D9 000CCC0E632C 000CCC0E6325 000CCC0E6326 000CCC0E64E2 000CCC0E6322 000CCC0E64E0 000CCC0E64E3 000CCC0E6327 000CCC0E6328 000CCC0E632B 000CCC0E64DC 000CCC0E64DA 000CCC0E6324 000CCC0E6323 000CCC0E6321 000CCC0E6469 000CCC0E62F6 000CCC0E6465 000CCC0E62F1 000CCC0E62F4 000CCC0E62F9 000CCC0E646A 000CCC0E62F5 000CCC0E62F3 000CCC0E646C 000CCC0E6468 000CCC0E6466 000CCC0E62F7 000CCC0E62FC 000CCC0E6464 000CCC0E6462 000CCC0E62FA 000CCC0E6467 000CCC0E62F2 000CCC0E6461 000CCC0E62FB 000CCC0E646B 000CCC0E62F8 000CCC0E6463 000CCC0E648D 000CCC0E648E 000CCC0E6486 000CCC0E64A2 000CCC0E6488 000CCC0E6487 000CCC0E64A8 000CCC0E648C 000CCC0E64A3 000CCC0E648A 000CCC0E649E 000CCC0E648F 000CCC0E649F 000CCC0E64A5 000CCC0E6490 000CCC0E6485 000CCC0E64A0 000CCC0E64A4 000CCC0E64A1 000CCC0E649D 000CCC0E64A6 000CCC0E6489 000CCC0E648B 000CCC0E64A7 000CCC0E626C 000CCC0E6268 000CCC0E626B 000CCC0E6371 000CCC0E6267 000CCC0E6373 000CCC0E636A 000CCC0E636B 000CCC0E6266 000CCC0E636F 000CCC0E6263 000CCC0E6370 000CCC0E636D 000CCC0E626A 000CCC0E6264 000CCC0E6369 000CCC0E6269 000CCC0E636E 000CCC0E636C 000CCC0E62F0 000CCC0E62E6 000CCC0E62EC 000CCC0E62C2 000CCC0E62E8 000CCC0E62ED 000CCC0E62C4 000CCC0E62E5 000CCC0E6258 000CCC0E64CD 000CCC0E64D0 000CCC0E64CE 000CCC0E64D8 000CCC0E64D5 000CCC0…
UPC codes
00840948102660

Products covered by this recall

Arial 900 MHz Call Station, Model Number CSK200-900MR, 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.

  • 00840948102660

Model or item number

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

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

Serial number

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

  • 000CCC0E6CC9 000CCC0E6CC6 000CCC0E6CCC 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 — A malfunction was identified in this device. What matters most is whether your particular unit falls inside the affected model, lot or serial range.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers listed on this page.
  2. If the device is implanted, or you depend on it daily, speak to your clinician before changing anything about how you use it.
  3. Check whether the remedy is a software update, and if so confirm afterwards in the device menu that the version actually changed.
  4. If you are a clinic or facility, quarantine affected stock and record the correction in your recall log.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

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 00840948102660; model number CSK200-900MR, 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?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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