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Spacelabs Healthcare, Inc.

26 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Brand Name: Xhibit Product Name: Xhibit Central Station Model/Catalog Number: 96102 Softwa recall (Z-2916-2026)Spacelabs Healthcare, Inc.2026-08-07
Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Ca recall (Z-2052-2026)Spacelabs Healthcare, Inc.2026-05-01
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor recall (Z-1793-2026)Spacelabs Healthcare, Inc.2026-04-07
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Mode recall (Z-0167-2026)Spacelabs Healthcare, Inc.2025-10-16
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Mode recall (Z-0168-2026)Spacelabs Healthcare, Inc.2025-10-16
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Mode recall (Z-0169-2026)Spacelabs Healthcare, Inc.2025-10-16
Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitorin recall (Z-0809-2025)Spacelabs Healthcare, Inc.2025-01-07
Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring syste recall (Z-0810-2025)Spacelabs Healthcare, Inc.2025-01-07
Ultraview SL (UVSL) Command Module, Model 91496 recall (Z-1503-2023)Spacelabs Healthcare, Inc.2023-05-03
Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1, physiol recall (Z-0532-2018)Spacelabs Healthcare Inc2018-01-25
Xhibit Central Station, Model 96102. Intended use is to provide clinicians with central mo recall (Z-0332-2017)Spacelabs Healthcare Inc2016-11-02
Spacelabs Healthcare Xhibit Central Station, Model 96102, Version 1.1.2. Xhibit Telemetry recall (Z-2885-2016)Spacelabs Healthcare Inc2016-09-26
Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280. Xhibit Telemetry Receiv recall (Z-2886-2016)Spacelabs Healthcare Inc2016-09-26
91496 Ultraview SL Command Module, Options A, B, C, and I. Option A: ECG/Respiration, SpO2 recall (Z-2343-2016)Spacelabs Healthcare Inc2016-08-04
Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4, PCB recall (Z-0172-2016)Spacelabs Healthcare Inc2015-10-30
Spacelabs qube Compact Monitor, Model 91390. The monitor is functioning as either bedside recall (Z-1608-2015)Spacelabs Healthcare Inc2015-05-13
Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The recall (Z-1577-2015)Spacelabs Healthcare Inc2015-05-04
Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product recall (Z-1542-2015)Spacelabs Healthcare Inc2015-04-28
Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393. The Spacelabs Healthcare XPREZ recall (Z-1144-2015)Spacelabs Healthcare Inc2015-02-24
Spacelabs Healthcare qube Compact Monitor, Model 91390. The Spacelabs Healthcare qube Comp recall (Z-1145-2015)Spacelabs Healthcare Inc2015-02-24
Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Dete recall (Z-2707-2014)Spacelabs Healthcare Inc2014-09-25
ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient mon recall (Z-2586-2014)Spacelabs Healthcare Inc2014-09-04
Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09). Pro recall (Z-2077-2014)Spacelabs Healthcare Inc2014-07-17
Spacelabs Healthcare Qube Compact Monitor, Model 91390. Intended to alert the user to alar recall (Z-1852-2014)Spacelabs Healthcare Inc2014-06-23
Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07 recall (Z-1824-2014)Spacelabs Healthcare Inc2014-06-18
Spacelabs Medical Ultraview SL Command Module, Model 91496. Arrhythmia Detector and Alarm. recall (Z-1705-2014)Spacelabs Healthcare Inc2014-06-03

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Every clearance here is in the API, with alerts when new ones post.