| 2026-03-26 |
Class II
|
Ongoing |
Z-2052-2026 |
Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Softwar… |
— |
Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester). |
| 2026-02-27 |
Class II
|
Ongoing |
Z-1793-2026 |
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor |
— |
Multi-parameter command module has a circuit board issue and when in Auto mode, Cardiac Output (CO) measurement may activate early, resulting in Bad Curve error… |
| 2025-09-16 |
Class II
|
Ongoing |
Z-0416-2026 |
Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version: 11.6.0 Product Des… |
— |
Due to two distinct issues: 1. During patient admission, patient demographic fields may default to those of a previously viewed patient. 2. Systems configure… |
| 2025-09-05 |
Class II
|
Ongoing |
Z-0169-2026 |
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0893-0… |
— |
Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk t… |
| 2025-09-05 |
Class II
|
Ongoing |
Z-0168-2026 |
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-1… |
— |
Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk t… |
| 2025-09-05 |
Class II
|
Ongoing |
Z-0167-2026 |
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-0… |
— |
Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk t… |
| 2024-11-25 |
Class II
|
Ongoing |
Z-0810-2025 |
Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data. |
— |
Telemetry receivers with affected software versions may experience unsolicited system shut down and restart (Offline displayed), lasting approximately 1 to 1.5 … |
| 2024-11-25 |
Class II
|
Ongoing |
Z-0809-2025 |
Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data. |
— |
Telemetry receiver systems may experience a Windows proxy Issue causing the system to shut down and restart (Offline displayed), lasting approximately 1 to 1.5 … |
| 2024-11-25 |
Class II
|
Ongoing |
Z-0685-2025 |
Eclipse Mini REF 98900 The Eclipse MINI Model 98900 is a portable non-invasive continuous ambulatory ECG patch record… |
— |
Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter recorder. The physical serial number label on the de… |
| 2024-11-25 |
Class II
|
Ongoing |
Z-0684-2025 |
Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the pat… |
— |
Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter recorder. The physical serial number label on the de… |
| 2023-04-12 |
Class II
|
Ongoing |
Z-1503-2023 |
Ultraview SL (UVSL) Command Module, Model 91496 |
— |
Command modules will display the following when parameter processing is suspended, depending on software version: 1) Older versions will have waveforms present … |
| 2022-05-31 |
Class II
|
Ongoing |
Z-1513-2022 |
Xhibit Telemetry Receiver, Model: 96280 |
— |
Software related alarm escalation defect occurs after approximately 25 days of continuous use. Technical alarm escalation for the following alarms, signal loss,… |
| 2020-11-06 |
Class II
|
Terminated |
Z-0563-2021 |
Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usage: designed using the latest programming technology and is e… |
— |
During system upgrade incorrect comments may be added to existing tests. In such instance: Resting ECG and ABP tests which did not contain comments at the time … |