Spacelabs Healthcare Inc

Complete recall history across all FDA and CPSC categories — 19 total recalls

Spacelabs Healthcare Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (19)

FDA medical device enforcement actions by Spacelabs Healthcare Inc

Date Product Reason Class
Jan 17, 2018 Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version... Spacelabs has received multiple complaints reporting telemetry beds dropping ... Class II
Oct 18, 2016 Xhibit Central Station, Model 96102. Intended use is to provide clinicia... The firm received reports of telemetry SpO2 numerics dropping off the Xhibit ... Class II
Aug 25, 2016 Spacelabs Healthcare Xhibit Central Station, Model 96102, Version 1.1.2. Xh... The firm received multiple reports of Xhibit Telemetry System going offline o... Class II
Aug 25, 2016 Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280. Xhibit Te... The firm received multiple reports of Xhibit Telemetry System going offline o... Class II
Jul 1, 2016 91496 Ultraview SL Command Module, Options A, B, C, and I. Option A: ECG/R... The firm has received multiple reports of the Non-Invasive Blood Pressure (NI... Class II
Mar 28, 2016 The Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280 is used... Reports of an abnormally high frequency of squelch events on Xhibit Telemetry... Class II
Feb 26, 2016 Spacelabs Healthcare Xhibit Central Station, Model 96102 is used to provide c... The firm has received one report of values for patient height and weight bein... Class II
Sep 3, 2015 Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80... When the battery is inserted into the CardioCall ECG Event Recorder, the devi... Class II
May 8, 2015 Spacelabs qube Compact Monitor, Model 91390. The monitor is functioning as e... The input power can fail even though the power source at the wall has not bee... Class II
Apr 21, 2015 Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 01... Modules resetting. This failure mode happens when the Spacelabs Command Modul... Class II
Apr 17, 2015 Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 O... Ultraview SL Command Modules which were upgraded with the Masimo SpO2 Option,... Class II
Jan 28, 2015 Spacelabs Healthcare qube Compact Monitor, Model 91390. The Spacelabs He... Spacelabs Healthcare qube Bedside Monitors, Model 91390, are recalled because... Class II
Jan 28, 2015 Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393. The Spacelabs He... Spacelabs Healthcare XPREZZON Bedside Monitors, Model 91393, are recalled bec... Class II
Aug 26, 2014 Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Ar... The clinician did not realize the monitor was in END CASE mode and was expect... Class II
Jul 2, 2014 ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiologic... The transmitter display and the Telemetry Central Station display may show a ... Class II
Jun 18, 2014 Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.0... With this software version, the Minimum Alveolar Concentration (MAC) value di... Class II
Jun 6, 2014 Spacelabs Healthcare Qube Compact Monitor, Model 91390. Intended to alert ... Spacelabs Healthcare is recalling Qube Compact Monitor, Model 91390, due to a... Class II
May 9, 2014 Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07 Spacelabs Healthcare is voluntarily recalling the Hamilton Galileo Ventilator... Class II
May 8, 2014 Spacelabs Medical Ultraview SL Command Module, Model 91496. Arrhythmia De... A software anomaly causes temperature alarm limits to change to limits which ... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

Explore More Recalls

Search recalls by category, state, reason, or firm across all our databases.