FDA recall record · openFDA

Spacelabs Healthcare, Inc.

8 FDA recalls on record (2023–2026) — 8 device. 8 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shiel 3

Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester). 1

Telemetry receiver systems may experience a Windows proxy Issue causing the system to shut down and restart (Offline dis 1

Telemetry receivers with affected software versions may experience unsolicited system shut down and restart (Offline dis 1

Command modules will display the following when parameter processing is suspended, depending on software version: 1) Old 1

Recalls

Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Softwar Class II 2026-03-26 Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor Class II 2026-02-27 Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0893-0 Class II 2025-09-05 Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-1 Class II 2025-09-05 Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-0 Class II 2025-09-05 Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data. Class II 2024-11-25 Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data. Class II 2024-11-25 Ultraview SL (UVSL) Command Module, Model 91496 Class II 2023-04-12

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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