Spacelabs Healthcare, Ltd.
FDA Regulatory Profile
Spacelabs Healthcare, Ltd. appears in FDA public data with 46 recalls — including 2 Class I (most serious) —, 20 510(k) clearances, 8 FDA inspections, and 2 compliance actions on record. Its most recent recall (Z-2052-2026, Class II) was initiated on March 26, 2026. Its most recent 510(k) clearance was granted on November 7, 2022.
Summary
- Total Recalls
- 46 (2 Class I)
- 510(k) Clearances
- 20
- Inspections
- 8
- Compliance Actions
- 2
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2052-2026 | Class II | Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Nu | March 26, 2026 |
| Z-1793-2026 | Class II | Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor | February 27, 2026 |
| Z-0416-2026 | Class II | Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version: | September 16, 2025 |
| Z-0169-2026 | Class II | Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalo | September 5, 2025 |
| Z-0167-2026 | Class II | Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalo | September 5, 2025 |
| Z-0168-2026 | Class II | Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalo | September 5, 2025 |
| Z-0684-2025 | Class II | Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intend | November 25, 2024 |
| Z-0810-2025 | Class II | Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with pa | November 25, 2024 |
| Z-0809-2025 | Class II | Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system | November 25, 2024 |
| Z-0685-2025 | Class II | Eclipse Mini REF 98900 The Eclipse MINI Model 98900 is a portable non-invasive continuous ambulat | November 25, 2024 |
| Z-1503-2023 | Class II | Ultraview SL (UVSL) Command Module, Model 91496 | April 12, 2023 |
| Z-1513-2022 | Class II | Xhibit Telemetry Receiver, Model: 96280 | May 31, 2022 |
| Z-0563-2021 | Class II | Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usage: designed using the latest programming | November 6, 2020 |
| Z-2261-2020 | Class II | Xhibit Central, Model No. 96102 - Product Usage: intended use is to provide clinicians with central | August 30, 2019 |
| Z-2035-2019 | Class II | Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite | January 28, 2019 |
| Z-2589-2018 | Class I | Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00 | July 11, 2018 |
| Z-0532-2018 | Class II | Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1, physiological pat | January 17, 2018 |
| Z-0072-2018 | Class I | Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit 050-9043-00 | October 11, 2017 |
| Z-0332-2017 | Class II | Xhibit Central Station, Model 96102. Intended use is to provide clinicians with central monitor | October 18, 2016 |
| Z-2886-2016 | Class II | Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280. Xhibit Telemetry Receivers (XTR) | August 25, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K212317 | Eclipse MINI Model 98900 | November 7, 2022 |
| K211651 | Eclipse PRO | November 22, 2021 |
| K201921 | Spacelabs Lifescreen PRO Analyzer | March 26, 2021 |
| K152881 | SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM | April 1, 2016 |
| K150329 | elance Vital Signs Monitor, Central Monitor Software | November 5, 2015 |
| K141113 | SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVE | September 26, 2014 |
| K141156 | SPACELABS HEALTHCARE TELEMETRY RECEIVER | September 9, 2014 |
| K130207 | SPACELABS HEALTHCARE CARDIOEXPRESS | July 23, 2013 |
| K122146 | XHIBIT CENTRAL STATION, MODEL 96102 | April 22, 2013 |
| K130112 | CAPNO MODULE, 92517 | March 21, 2013 |
| K121017 | CAPNOGRAPHY PAD (92516) | July 13, 2012 |
| K112729 | BLEASE700/900 SERIES VENTILATORS | June 11, 2012 |
| K121480 | ARIATELE TELEMETRY TRANSMITTER (96281) | June 6, 2012 |
| K113051 | SPACELABS ARKON ANESTHESIA WORKSTATION | March 22, 2012 |
| K112173 | SPEACELABS MULTIGAS MODULE | October 5, 2011 |
| K110001 | SPACELABS PATHFINDER SL HOLTER ANALYZER | June 14, 2011 |
| K110779 | SPACELABS SMART DISCLOSURE SYSTEM | April 19, 2011 |
| K103142 | SPACELABS MULTI-PARAMETER MODULE | March 3, 2011 |
| K101850 | SPACELABS BLEASESIRIUS ANESTHESIA WORKSTATION | March 2, 2011 |
| K103732 | SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITOR | February 4, 2011 |