The Recall Desk

Manufacturer

Spacelabs Healthcare, Ltd.

6 recalls in our database name Spacelabs Healthcare, Ltd. as the manufacturing or recalling firm.

What the numbers show

Total
6
Critical
0
Severe
2
Most recent
2025-11-12

Of the 6 recalls from Spacelabs Healthcare, Ltd. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (33%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–6 of 6

  • HighFDA (Devices)·Z-0416-2026·2025-11-12

    Cardiology records system recalled over data saved to the wrong patient

    Spacelabs Healthcare is recalling 142 Sentinel V11 cardiology information systems because patient demographics may default to a previous patient and test data may be saved under another patient's record.

    Product
    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 m
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0684-2025·2024-12-25

    Eclipse PRO Holter Recorders Recalled for Serial Number Mismatch

    Spacelabs Healthcare recalls 13,202 Eclipse PRO Holter recorders due to manufacturing error where the programmed serial number may not match the physical label. Affected devices were manufactured between April 2021 and November 2024.

    Product
    Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory electrocardiogram.
    Category
    Medical Device
    Distribution
    22 states
  • ModerateFDA (Devices)·Z-0685-2025·2024-12-25

    ECG Patch Recorder Serial Number Mismatch - Eclipse Mini

    Spacelabs Healthcare is recalling the Eclipse Mini ECG patch recorder because incorrect serial numbers may be programmed into devices, causing a mismatch between the physical label and internal serial number.

    Product
    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.
    Category
    Medical Device
    Distribution
    22 states
  • ModerateFDA (Devices)·Z-0563-2021·2020-12-16

    Spacelabs Sentinel V10 and V11 Software Upgrade Recall

    Spacelabs Healthcare is recalling Sentinel V10.x and V11.x software because system upgrades may add or overwrite unrelated comments on existing ECG and ABP tests.

    Product
    Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usage: designed using the latest programming technology and is easy to install and to use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2589-2018·2018-08-22

    Spacelabs Arkon Anesthesia Delivery System Recalled for Ventilation Failure Risk

    Spacelabs Healthcare is recalling 328 Arkon Anesthesia Delivery Systems because they may stop providing mechanical ventilation while in use or idle.

    Product
    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 roo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0072-2018·2017-11-29

    Spacelabs Arkon Anesthesia Workstation Recalled for Mechanical and Display Failures

    Spacelabs Healthcare is recalling 110 Arkon Anesthesia Workstations due to failures in ventilation, gas delivery, and display alarms.

    Product
    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 nitrou
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Spacelabs Healthcare

American medical equipment manufacturer

Country
United States
Founded
1958
Parent company
OSI Systems

Official website

Source: Wikidata (Q7572694), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.