PlainRecalls

Spacelabs Healthcare, Ltd.

Compiled from official public sources by the publisher.

6 recalls on record · Latest: Nov 12, 2025

Subscribe to new Spacelabs Healthcare, Ltd. recalls (RSS)

Agency notice ledger

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

#2,298 of 14,151 · 6 notices · 0.006% archive

  • BOOK 6 notices
  • RANK #2,298 of 14,151
  • SHARE 0.006% archive
  • AGENCY FDA Devices (6)
  • CAT medical devices
  • CATS 1 category
  • LATEST Nov 12, 2025
  • PHOTO 1908 Brands

Nearest notice-volume peer: 1908 Brands (0 notice gap)

Spacelabs Healthcare, Ltd. accounts for about 0.006% of the 104,423-notice archive on 6 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, Ltd.'s standing among 14,151 recalling firms

Spacelabs Healthcare, Ltd. ranks 2,298th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Spacelabs Healthcare, Ltd. vs all firms by recall-notice count

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

6 2298th of 14151 higher than 11,804 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, Ltd. in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Spacelabs Healthcare, Ltd. holds about 0.006% of archive notices alongside 6 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Nov 12, 2025

Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version: 11.6.0 Product Description: Cardiology Information Management System Component: No The Sentinel Cardiology Information Management System is intended to connect to supported medical devices and analyzers in order to download, store, access and manage cardiovascular information and to manage patient and facility information.
FDA Devices Moderate Dec 25, 2024

Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory electrocardiogram.
FDA Devices Moderate Dec 25, 2024

Eclipse Mini REF 98900 The Eclipse MINI Model 98900 is a portable non-invasive continuous ambulatory ECG patch recorder intended to record the patient s electrocardiogram.
FDA Devices Moderate Dec 16, 2020

Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usage: designed using the latest programming technology and is easy to install and to use.
FDA Devices Critical Aug 22, 2018

Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00 installed, and Model #: 99999. This system includes a ventilator. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anest
FDA Devices Critical Nov 29, 2017

Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit 050-9043-00 Rev G. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. The device i

Spacelabs Healthcare, Ltd. holds a measurable archive slice

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

Similar recall count

Nearest multi-notice firms by distinct-event totals (6 here).

1908 Brands 6 Abbott Molecular 6 Accriva Diagnostics, Inc. 6 Advance Medical Designs, Inc. 6 Agave Dream 6

Similar medical devices volume

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

Abbott Molecular 6 Accriva Diagnostics, Inc. 6 Advance Medical Designs, Inc. 6 American Medical Systems, Inc. 6

Frequently Asked Questions

How many federal recall notices name Spacelabs Healthcare, Ltd.? ▼
PlainRecalls indexes 6 distinct federal recall events naming Spacelabs Healthcare, Ltd., 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, Ltd. sit among other recalling firms? ▼
Spacelabs Healthcare, Ltd. ranks #2,298 of 14,151 by distinct recall-event count among 14,151 firms in this archive (83rd percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Spacelabs Healthcare, Ltd.'s notices? ▼
FDA Devices accounts for 6 of this firm's 6 indexed notices.
What product category dominates Spacelabs Healthcare, Ltd.'s filing book? ▼
Filings for Spacelabs Healthcare, Ltd. 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, Ltd.: 6 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, Ltd.; individual notices remain authoritative on each linked recall page.

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