Arial
REFURBISHED - Arial Wireless Water-Resistant Pendant ES with Long Wristband
1manufacturer
96catalogue numbers in this listing
12recalls on this code
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Yuiyn HOO Industrial Limited | Dong Guan | Guangdong | Contract manufacturer | 3 |
Record
| Listed by | Securitas Healthcare LLC, United States |
|---|---|
| FDA product code | IQA |
| Device type | System, Environmental Control, Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 890.3725 |
| Establishment | Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-23 |
| Record revised | 2024-02-29 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, serial number |
| Sizes | Length 7 to 15 ft |
| Distribution end date | 2022-09-20 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 54351 | In distribution | |
| 59362 | In distribution | |
| 54360-900 | In distribution | |
| 0900-652 | In distribution | |
| 14390 | In distribution | |
| 0900-989 | In distribution | |
| 54305 | In distribution | |
| 0850-173 | In distribution | |
| 54357 | In distribution | |
| 59350 | In distribution | |
| CSK200-1069MR | In distribution | |
| 0200-116 | In distribution | |
| 0900-696 | In distribution | |
| 2560-54357 | In distribution | |
| 2560-54311 | In distribution | |
| CSK200-1069 | In distribution | |
| 52114 | In distribution | |
| 54350 | In distribution | |
| 2560-59360R | In distribution | |
| 54313 | In distribution | |
| 54742 | In distribution | |
| 52112 | In distribution | |
| CSK200-MR | In distribution | |
| 2560-54343 | In distribution | |
| 54382 | In distribution | |
| 2560-54351 | In distribution | |
| 2560-59361 | In distribution | |
| 14390-AUS | In distribution | |
| 54311 | In distribution | |
| 2560-14390 | In distribution | |
| 59364 | In distribution | |
| 0707-348 | Length 15 ft | In distribution |
| 54021 | In distribution | |
| 2560-55352 | In distribution | |
| 2560-54337 | In distribution | |
| 54312 | In distribution | |
| 2560-59362 | In distribution | |
| 54390 | In distribution | |
| 54302 | In distribution | |
| 54360 | In distribution | |
| TAG-P1000-W | In distribution | |
| 14321 | In distribution | |
| 1069-54370 | In distribution | |
| 0900-695 | In distribution | |
| 2560-55365 | In distribution | |
| 54326 | In distribution | |
| 54180 | In distribution | |
| 0707-1151 | In distribution | |
| 54743 | In distribution | |
| 2560-59362R | In distribution | |
| 2560-55351 | In distribution | |
| 55365 | In distribution | |
| 2560-59364 | In distribution | |
| 2560-54350 | In distribution | |
| 2560-54336 | In distribution | |
| 2560-54313 | In distribution | |
| 55352 | In distribution | |
| 59360 | In distribution | |
| 59362R | In distribution | |
| 2560-54312 | In distribution | |
| 54321 | In distribution | |
| 59360R | In distribution | |
| 0900-241 | Length 7 ft | In distribution |
| 59361 | In distribution | |
| 0900-353 | In distribution | |
| 55351 | In distribution | |
| 54336 | In distribution | |
| 55350 | In distribution | |
| 2560-54360 | In distribution | |
| 54343 | In distribution | |
| 0900-639 | In distribution | |
| CSK200-900 | In distribution | |
| 52116 | In distribution | |
| 0707-479 | In distribution | |
| 2560-59360 | In distribution | |
| 0900-240 | Length 7 ft | In distribution |
| 54330 | In distribution | |
| 0850-046 | In distribution | |
| 2560-59361R | In distribution | |
| 2560-55350 | In distribution | |
| 54745 | In distribution | |
| 0850-217 | In distribution | |
| 54337 | In distribution | |
| 2560-54321 | In distribution | |
| 0850-222 | In distribution | |
| 54600 | In distribution | |
| 54385 | In distribution | |
| CSK200 | In distribution | |
| 59361R | In distribution | |
| CSK200-900MR | In distribution | |
| 54744 | In distribution | |
| 54026 | Withdrawn | |
| 54037 | Withdrawn | |
| 54036 | Withdrawn | |
| 54315 | Withdrawn | |
| 54010 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| GEN4 Digital | Curbell Medical Products, Inc. | 922 |
| GEN4 Interactive | Curbell Medical Products, Inc. | 456 |
| GEN4 Plus, Direct Access | Curbell Medical Products, Inc. | 142 |
| Ascom | Ascom Sweden AB | 77 |
| Elite Digital | Crest Healthcare Supply | 71 |
| Amplion Care Assurance | Amplion Clinical Communications, Inc. | 67 |
| Elite Infrared | Crest Healthcare Supply | 59 |
| Responder 5, Standard | Curbell Medical Products, Inc. | 33 |
| Excel Digital | Crest Healthcare Supply | 28 |
| Responder 5, Standard,no Entertainment | Curbell Medical Products, Inc. | 28 |
| Excel EntertainIR | Crest Healthcare Supply | 24 |
| GEN4 Direct Access | Curbell Medical Products, Inc. | 23 |
Showing 12 of 819. All products under System, Environmental Control, Powered
Recalls Naming This Product
5 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Securitas Healthcare LLC | UDI-DI | 2025-12-08 | Class II | Under Investigation by firm | 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 | 5627 units |
| Securitas Healthcare LLC | UDI-DI | 2025-12-08 | Class II | Under Investigation by firm | 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 | 1898 units |
| Securitas Healthcare LLC | UDI-DI | 2024-04-11 | Class II | Under Investigation by firm | The Arial Mobile Application utilizing Apple iOS 17.4 and iOS 17.5 is frequently restarting causing the app to receive alerts for all pending alarm notifications and other events when the app restarts, experience difficulty in placing and | 661 sites with mobile application user licenses |
| Securitas Healthcare LLC | UDI-DI | 2023-02-06 | Class II | Under Investigation by firm | The mobile application for Android devices downloaded from the Google Play Store do not load per specifications and function on the Android devices. | Approximately 350 downloads |
| Securitas Healthcare LLC | UDI-DI | 2021-11-17 | Class II | Component design/selection | Systems are not alarming due to increased memory consumption. | 11 units (systems) |
Recalls
7 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2024-11-01 | Class II | Software Design Change | Certain software versions will not notify end users of calls initiated by call points with the Arial Emergency and Nurse Call System. | 111 systems | |
| 2024-06-20 | Class II | Software Manufacturing/Software Deployment | There is a risk that alarms will not be received by the Arial Wireless Emergency Call System and premature depletion of the battery. | 1268 units | |
| 2024-06-20 | Class II | Software Manufacturing/Software Deployment | This is a risk that alarms will not be received by the Arial Wireless Nurse Call System and premature depletion of the battery. | 77 units | |
| 2023-09-25 | Class II | Component change control | Premature battery depletion presents a risk that alarms will not be received by the Arial Wireless Emergency Call System. | 2691 units | |
| 2023-09-25 | Class II | Component change control | Premature battery depletion presents a risk that alarms will not be received by the Arial Wireless Emergency Call System. | 1235 units | |
| 2023-09-25 | Class II | Component change control | Premature battery depletion presents a risk that alarms will not be received by the Arial Wireless Emergency Call System. | 49 devices | |
| 2019-06-14 | Class II | Under Investigation by firm | STANLEY Healthcare has received reports of outages on the Arial nurse call system. These outages have been traced back to the Arial 54315 Serial-to-IP Network Gateway. | 137 units | 2021-05-13 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.