Spacelabs Healthcare recalls
Spacelabs Healthcare appears in 47 official U.S. recall notices indexed by RecallRadar, most recently on 2026-08-19.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- Brand Name: Xhibit Product Name: Xhibit Central Station Model/Catalog Number: 96102 Software Version: N/A Product Description: The Spacelab…
FDA Device · Class II · 2026-08-19 · Spacelabs Healthcare - Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software Version: N/A Product…
FDA Device · Class II · 2026-05-13 · Spacelabs Healthcare - Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Device · Class II · 2026-04-15 · Spacelabs Healthcare - Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version: 11.6.0 Product Description: Cardiology In…
FDA Device · Class II · 2025-11-12 · Spacelabs Healthcare - Brand Name: Branding is not applied to this product
FDA Device · Class II · 2025-10-22 · Spacelabs Healthcare - Brand Name: Branding is not applied to this product
FDA Device · Class II · 2025-10-22 · Spacelabs Healthcare - Brand Name: Branding is not applied to this product
FDA Device · Class II · 2025-10-22 · Spacelabs Healthcare - Xhibit Telemetry Receiver with Software, Model 96280
FDA Device · Class II · 2025-01-15 · Spacelabs Healthcare - Xhibit Telemetry Receiver, Model 96280, with Service Manual
FDA Device · Class II · 2025-01-15 · Spacelabs Healthcare - Eclipse Mini REF 98900 The Eclipse MINI Model 98900 is a portable non-invasive continuous ambulatory ECG patch recorder intended to record…
FDA Device · Class II · 2024-12-25 · Spacelabs Healthcare - Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory elec…
FDA Device · Class II · 2024-12-25 · Spacelabs Healthcare - Ultraview SL (UVSL) Command Module, Model 91496
FDA Device · Class II · 2023-05-10 · Spacelabs Healthcare - Xhibit Telemetry Receiver, Model: 96280
FDA Device · Class II · 2022-08-17 · Spacelabs Healthcare - Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usage: designed using the latest programming technology and is easy to install and…
FDA Device · Class II · 2020-12-16 · Spacelabs Healthcare - Xhibit Central, Model No. 96102 - Product Usage: intended use is to provide clinicians with central monitoring of adult, pediatric and neon…
FDA Device · Class II · 2020-06-10 · Spacelabs Healthcare - Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2
FDA Device · Class II · 2019-07-31 · Spacelabs Healthcare - Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00 installed, and Model #: 99999
FDA Device · Class I · 2018-08-22 · Spacelabs Healthcare - Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1, physiological patient monitor (with arrhythmia detection…
FDA Device · Class II · 2018-02-14 · Spacelabs Healthcare - Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit 050-9043-00 Rev G. The Spacelabs Arkon Anesthesia…
FDA Device · Class I · 2017-11-29 · Spacelabs Healthcare - Xhibit Central Station, Model 96102
FDA Device · Class II · 2016-11-09 · Spacelabs Healthcare - Spacelabs Healthcare Xhibit Central Station, Model 96102, Version 1.1.2. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Ce…
FDA Device · Class II · 2016-10-05 · Spacelabs Healthcare - Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280
FDA Device · Class II · 2016-10-05 · Spacelabs Healthcare - 91496 Ultraview SL Command Module, Options A, B, C, and I. Option A: ECG/Respiration, SpO2, Temperature x2 & adult/neonate NIBP. Option B:…
FDA Device · Class II · 2016-08-10 · Spacelabs Healthcare - The Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280 is used to transmit patient(s) physiological measurements and data to…
FDA Device · Class II · 2016-04-27 · Spacelabs Healthcare - Spacelabs Healthcare Xhibit Central Station, Model 96102 is used to provide clinicians with central monitoring of patient data for those pa…
FDA Device · Class II · 2016-03-16 · Spacelabs Healthcare - Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4, PCBAs PN # 670-1670-00 Product Usage: The CardioCall…
FDA Device · Class II · 2015-11-04 · Spacelabs Healthcare - Spacelabs qube Compact Monitor, Model 91390
FDA Device · Class II · 2015-05-20 · Spacelabs Healthcare - Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02
FDA Device · Class II · 2015-05-13 · Spacelabs Healthcare - Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option
FDA Device · Class II · 2015-05-06 · Spacelabs Healthcare - Spacelabs Healthcare qube Compact Monitor, Model 91390
FDA Device · Class II · 2015-03-04 · Spacelabs Healthcare - Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393
FDA Device · Class II · 2015-03-04 · Spacelabs Healthcare - Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms
FDA Device · Class II · 2014-10-01 · Spacelabs Healthcare - ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient monitor
FDA Device · Class II · 2014-09-10 · Spacelabs Healthcare - Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09)
FDA Device · Class II · 2014-07-23 · Spacelabs Healthcare - Spacelabs Healthcare Qube Compact Monitor, Model 91390
FDA Device · Class II · 2014-07-02 · Spacelabs Healthcare - Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07
FDA Device · Class II · 2014-06-25 · Spacelabs Healthcare - Spacelabs Medical Ultraview SL Command Module, Model 91496
FDA Device · Class II · 2014-06-11 · Spacelabs Healthcare - Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Rev A and Update Kit, PN: 040-1565-10
FDA Device · Class II · 2014-04-02 · Spacelabs Healthcare - ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient popu…
FDA Device · Class II · 2014-02-05 · Spacelabs Healthcare - Spacelabs Healthcare qube Compact Patient Monitor, Model 91390
FDA Device · Class II · 2013-11-27 · Spacelabs Healthcare - Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms
FDA Device · Class II · 2013-11-20 · Spacelabs Healthcare - Spacelabs Smart Disclosure System, Model 92810, is an integrated component of the Intesys Clinical Suite (ICS) G2, Version 4.03
FDA Device · Class II · 2013-01-23 · Spacelabs Healthcare - qube Compact Monitor (Patient Monitor) 91390
FDA Device · Class II · 2012-11-28 · Spacelabs Healthcare - The touchscreen display (model 94267) designed for use with the XPREZZON bedside monitor (model 91393) is width-452 mm (17.2 inches) and he…
FDA Device · Class II · 2012-11-14 · Spacelabs Healthcare - Ultraview SL 91493 Integrated Module Housing
FDA Device · Class II · 2012-09-26 · Spacelabs Healthcare - Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, installations with Option C. It is a patient monitor with arrhythmia detection or…
FDA Device · Class II · 2012-07-25 · Spacelabs Healthcare - The product is Pathfinder SL, version 1.6.0.3057 software used with the Spacelabs Healthcare Pathfinder SL Holter Analyzer, version 1.6.0.…
FDA Device · Class II · 2012-06-27 · Spacelabs Healthcare