Spacelabs Healthcare, Llc
Complete recall history across all FDA and CPSC categories — 10 total recalls
Spacelabs Healthcare, Llc 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 (10)
FDA medical device enforcement actions by Spacelabs Healthcare, Llc
| Date | Product | Reason | Class |
|---|---|---|---|
| Feb 14, 2014 | Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Re... | Spacelabs has voluntarily recalled G2 Clinical Access Software CD because the... | Class II |
| Dec 19, 2013 | ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 962... | The AriaTele Model 96281 with SpO2 monitoring Option C is recalled because th... | Class II |
| Oct 17, 2013 | Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. ... | Spacelabs Healthcare elance Vital Signs Monitor with Option S, model 93330, i... | Class II |
| Oct 17, 2013 | Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a pati... | Spacelabs Healthcare qube Compact Patient Monitor, Model 91390, may fail to p... | Class II |
| Dec 5, 2012 | Spacelabs Smart Disclosure System, Model 92810, is an integrated component of... | Displaying or printing of an incorrect waveform for the time indicated in the... | Class II |
| Oct 19, 2012 | qube Compact Monitor (Patient Monitor) 91390. The monitor is 26.2 cm x 31.5 ... | Spacelabs Healthcare has learned through several reports that the input circ... | Class II |
| Oct 5, 2012 | The touchscreen display (model 94267) designed for use with the XPREZZON beds... | Potential failure of Spacelabs Healthcare Touchscreen Display, Model 94267 wh... | Class II |
| Aug 27, 2012 | Ultraview SL 91493 Integrated Module Housing. PCIS patient monitors is int... | There is a potential failure of the Integrated Module Housing causing the pat... | Class II |
| Jun 12, 2012 | Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, installations with O... | There were reports that a certain combination of key presses will cause the m... | Class II |
| May 11, 2012 | The product is Pathfinder SL, version 1.6.0.3057 software used with the Space... | The firm received reports of the Pathfinder LS software crashing after editin... | 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.
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