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Spacelabs Healthcare, Inc. FDA Recalls
10 recalls on file across devices, 0 of them Class I and 10 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
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| Brand Name: Xhibit Product Name: Xhibit Central Station Model/Catalog Number: 96102 Software Version: N/A Product DeClass IIJun 4, 2026Due to off-the-shelf display port component that has audio/v |
| Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 SoftwarClass IIMar 26, 2026Due to a manufacturing issue (i.e. malfunctioning of electri |
| Multi-parameter Command Module, Model 91496, optioned with Masimo or NellcorClass IIFeb 27, 2026Multi-parameter command module has a circuit board issue and |
| Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-1Class IISep 5, 2025Due to display cables used for monitors were not in complian |
| Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0893-0Class IISep 5, 2025Due to display cables used for monitors were not in complian |
| Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-0Class IISep 5, 2025Due to display cables used for monitors were not in complian |
| Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data.Class IINov 25, 2024Telemetry receiver systems may experience a Windows proxy Is |
| Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.Class IINov 25, 2024Telemetry receivers with affected software versions may expe |
| Ultraview SL (UVSL) Command Module, Model 91496Class IIApr 12, 2023Command modules will display the following when parameter pr |
| Xhibit Telemetry Receiver, Model: 96280Class IIMay 31, 2022Software related alarm escalation defect occurs after approx |