PlainRecalls

Spacelabs Healthcare, Llc

Compiled from official public sources by the publisher.

10 recalls on record · Latest: Apr 2, 2014

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Agency notice ledger

Federal filing book Spacelabs Healthcare, Llc LIGHT-BOOK · SINGLE-AGENCY

#1,528 of 14,151 · 10 notices · 0.010% archive

  • BOOK 10 notices
  • RANK #1,528 of 14,151
  • SHARE 0.010% archive
  • AGENCY FDA Devices (10)
  • CAT medical devices
  • CATS 1 category
  • LATEST Apr 2, 2014
  • PHOTO 4 Earth Farms formerl…

Nearest notice-volume peer: 4 Earth Farms formerly Mcl Fresh Inc (0 notice gap)

Spacelabs Healthcare, Llc accounts for about 0.010% of the 104,423-notice archive on 10 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Spacelabs Healthcare, Llc's standing among 14,151 recalling firms

Spacelabs Healthcare, Llc ranks 1,528th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Spacelabs Healthcare, Llc vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

10 1528th of 14151 higher than 12,602 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Spacelabs Healthcare, Llc in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Spacelabs Healthcare, Llc holds about 0.010% of archive notices alongside 10 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Apr 2, 2014

Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Rev A and Update Kit, PN: 040-1565-10. Used for installing ICS G2 Clinical Access software onto hospital personal computers.
FDA Devices Moderate Feb 5, 2014

ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.
FDA Devices Moderate Nov 27, 2013

Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhythmia detection or alarms. The qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment. These devices determine a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications.
FDA Devices Moderate Nov 20, 2013

Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.
FDA Devices Moderate Jan 23, 2013

Spacelabs Smart Disclosure System, Model 92810, is an integrated component of the Intesys Clinical Suite (ICS) G2, Version 4.03. The Smart Disclosure product collects patient waveforms, alarms, vital signs, and 12-lead reports. A 24-hour waveform acquisition is standard, with an upgrade option to 72 hours. The product provides basic trends in both tabular and graphical format, along with a retrospective ECG analysis. The analysis may be defined by patient, and the data may be presented in

FDA Devices Moderate Nov 28, 2012

qube Compact Monitor (Patient Monitor) 91390. The monitor is 26.2 cm x 31.5 cm x 13.2 cm and weighs 4.1 kg (10.3 inches x 12.4 inches x 5.2 inches - 9 lbs). It has a 26.2 cm (12.1 inches) LCD display with 1024 x 768 resolution. The Spacelabs Healthcare Qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by 2 Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and

FDA Devices Moderate Nov 14, 2012

The touchscreen display (model 94267) designed for use with the XPREZZON bedside monitor (model 91393) is width-452 mm (17.2 inches) and height- 368 mm (14.5 inches). The depth without the pedestal --- 67.7 mm (2.67 inches). The display is an integrated LCD 19-Inch. The Spacelabs Healthcare Xprezzon Bedside Monitor passively displays data generated by Spacelabs parameter modules.
FDA Devices Moderate Sep 26, 2012

Ultraview SL 91493 Integrated Module Housing. PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter module determines (a) when an alarm condition is violated; (b) the alarm priority (i.e. high, medium or low); (c) alarm limits; and (d) when to generate and terminate alarms. PCIS patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the
FDA Devices Moderate Jul 25, 2012

Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, installations with Option C. It is a patient monitor with arrhythmia detection or alarms. The Spacelabs Healthcare Xprezzon Bedside Monitor is intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other devices via Flexport interfaces. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature.

FDA Devices Moderate Jun 27, 2012

The product is Pathfinder SL, version 1.6.0.3057 software used with the Spacelabs Healthcare Pathfinder SL Holter Analyzer, version 1.6.0. Product Usage: The Holter Analyzer analyzes information collected from ambulatory electrocardiogram recorders worn by patients and used to assist physicians in diagnosis and patient monitoring. In addition, incorrect QTc values are reported after moving the cursor. QTc values are timing events between labeled points of interest in the ECG signal that the

Spacelabs Healthcare, Llc holds a measurable archive slice

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Amerx Health Care Corp. 10 Bausch & Lomb Surgical, Inc. 10 Beekley Corporation 10 Biocare Medical, LLC 10

Frequently Asked Questions

How many federal recall notices name Spacelabs Healthcare, Llc? ▼
PlainRecalls indexes 10 distinct federal recall events naming Spacelabs Healthcare, Llc, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Spacelabs Healthcare, Llc sit among other recalling firms? ▼
Spacelabs Healthcare, Llc ranks #1,528 of 14,151 by distinct recall-event count among 14,151 firms in this archive (89th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Spacelabs Healthcare, Llc's notices? ▼
FDA Devices accounts for 10 of this firm's 10 indexed notices.
What product category dominates Spacelabs Healthcare, Llc's filing book? ▼
Filings for Spacelabs Healthcare, Llc span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Spacelabs Healthcare, Llc: 10 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Spacelabs Healthcare, Llc; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026