Spacelabs Healthcare Inc

FDA Regulatory Profile

Summary

Total Recalls
44 (2 Class I)
510(k) Clearances
20
Inspections
8
Compliance Actions
2

Recent Recalls

NumberClassProductDate
Z-0416-2026Class IIBrand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version:September 16, 2025
Z-0169-2026Class IIBrand Name: Branding is not applied to this product. Product Name: DVI display cables Model/CataloSeptember 5, 2025
Z-0167-2026Class IIBrand Name: Branding is not applied to this product. Product Name: DVI display cables Model/CataloSeptember 5, 2025
Z-0168-2026Class IIBrand Name: Branding is not applied to this product. Product Name: DVI display cables Model/CataloSeptember 5, 2025
Z-0684-2025Class IIEclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intendNovember 25, 2024
Z-0685-2025Class IIEclipse Mini REF 98900 The Eclipse MINI Model 98900 is a portable non-invasive continuous ambulatNovember 25, 2024
Z-0809-2025Class IIXhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring systemNovember 25, 2024
Z-0810-2025Class IIXhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with paNovember 25, 2024
Z-1503-2023Class IIUltraview SL (UVSL) Command Module, Model 91496April 12, 2023
Z-1513-2022Class IIXhibit Telemetry Receiver, Model: 96280May 31, 2022
Z-0563-2021Class IISentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usage: designed using the latest programmingNovember 6, 2020
Z-2261-2020Class IIXhibit Central, Model No. 96102 - Product Usage: intended use is to provide clinicians with central August 30, 2019
Z-2035-2019Class IISpacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical SuiteJanuary 28, 2019
Z-2589-2018Class IArkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00July 11, 2018
Z-0532-2018Class IISpacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1, physiological patJanuary 17, 2018
Z-0072-2018Class IArkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit 050-9043-00October 11, 2017
Z-0332-2017Class IIXhibit Central Station, Model 96102. Intended use is to provide clinicians with central monitorOctober 18, 2016
Z-2886-2016Class IISpacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280. Xhibit Telemetry Receivers (XTR)August 25, 2016
Z-2885-2016Class IISpacelabs Healthcare Xhibit Central Station, Model 96102, Version 1.1.2. Xhibit Telemetry ReceiverAugust 25, 2016
Z-2343-2016Class II91496 Ultraview SL Command Module, Options A, B, C, and I. Option A: ECG/Respiration, SpO2, TempeJuly 1, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K212317Eclipse MINI Model 98900November 7, 2022
K211651Eclipse PRONovember 22, 2021
K201921Spacelabs Lifescreen PRO AnalyzerMarch 26, 2021
K152881SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEMApril 1, 2016
K150329elance Vital Signs Monitor, Central Monitor SoftwareNovember 5, 2015
K141113SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVESeptember 26, 2014
K141156SPACELABS HEALTHCARE TELEMETRY RECEIVERSeptember 9, 2014
K130207SPACELABS HEALTHCARE CARDIOEXPRESSJuly 23, 2013
K122146XHIBIT CENTRAL STATION, MODEL 96102April 22, 2013
K130112CAPNO MODULE, 92517March 21, 2013
K121017CAPNOGRAPHY PAD (92516)July 13, 2012
K112729BLEASE700/900 SERIES VENTILATORSJune 11, 2012
K121480ARIATELE TELEMETRY TRANSMITTER (96281)June 6, 2012
K113051SPACELABS ARKON ANESTHESIA WORKSTATIONMarch 22, 2012
K112173SPEACELABS MULTIGAS MODULEOctober 5, 2011
K110001SPACELABS PATHFINDER SL HOLTER ANALYZERJune 14, 2011
K110779SPACELABS SMART DISCLOSURE SYSTEMApril 19, 2011
K103142SPACELABS MULTI-PARAMETER MODULEMarch 3, 2011
K101850SPACELABS BLEASESIRIUS ANESTHESIA WORKSTATIONMarch 2, 2011
K103732SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITORFebruary 4, 2011