Spacelabs Healthcare, Ltd.
Complete recall history across all FDA and CPSC categories — 6 total recalls
Spacelabs Healthcare, Ltd. 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 (6)
FDA medical device enforcement actions by Spacelabs Healthcare, Ltd.
| Date | Product | Reason | Class |
|---|---|---|---|
| Sep 16, 2025 | Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 9... | Due to two distinct issues: 1. During patient admission, patient demographic... | Class II |
| Nov 25, 2024 | Eclipse Mini REF 98900 The Eclipse MINI Model 98900 is a portable non-inva... | Due to a manufacturing error the incorrect device serial number was potential... | Class II |
| Nov 25, 2024 | Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive... | Due to a manufacturing error the incorrect device serial number was potential... | Class II |
| Nov 6, 2020 | Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usage: designed using... | During system upgrade incorrect comments may be added to existing tests. In s... | Class II |
| Jul 11, 2018 | Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Un... | Arkon Anesthesia Delivery System may go into a failed state (mechanical venti... | Class I |
| Oct 11, 2017 | Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and ... | Arkon Anesthesia Workstation, with software version 2.61, experienced failure... | Class I |
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.
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