Spacelabs Healthcare recalls
10 official recalls and safety alerts involving Spacelabs Healthcare since 2022-08, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Spacelabs Healthcare or the relevant agency.
- 2026-08-19
USSpacelabs Healthcare, Inc. recalls Brand Name: Xhibit Product Name: Xhibit Central Station Model/Catalog Number: 96102 Software Version: N/A Product Description: The…
Due to off-the-shelf display port component that has audio/video failures
FDA · DeviceSpacelabs Healthcare, Inc.Worldwide - US Nationwide distribution in the states of AK, AL, AR, AZ, CA,…Official notice →- 2026-05-13
- US
Spacelabs Healthcare, Inc. recalls Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software Version: N/A…
Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester).
FDA · DeviceSpacelabs Healthcare, Inc.Worldwide - US Nationwide di GA, KS, MI, OH, SC, TX, WA and the country of…Official notice → - 2026-04-15
- US
Spacelabs Healthcare, Inc. recalls Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
Multi-parameter command module has a circuit board issue and when in Auto mode, Cardiac Output (CO) measurement may activate early, resulting in Bad Curve error with no CO measurement or Irregular Curve error with CO…
FDA · DeviceSpacelabs Healthcare, Inc.Worldwide - US Nationwide distribution including in the states of NY, NJ, AL,…Official notice → - 2025-11-12
- US
Spacelabs Healthcare, Ltd. recalls Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version: 11.6.0 Product Description:…
Due to two distinct issues: 1. During patient admission, patient demographic fields may default to those of a previously viewed patient. 2. Systems configured with Resting/Rhythm ECG functionality, under specific…
FDA · DeviceSpacelabs Healthcare, Ltd.Worldwide - US Nationwide distribution in the state of MN and the countries of…Official notice → - 2025-10-22
- US
Spacelabs Healthcare, Inc. recalls Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0893-01 Software…
Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of…
FDA · DeviceSpacelabs Healthcare, Inc.Worldwide - United States Nationwide distribution including in the states of…Official notice → - 2025-01-15
- US
Spacelabs Healthcare, Inc. recalls Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.
Telemetry receivers with affected software versions may experience unsolicited system shut down and restart (Offline displayed), lasting approximately 1 to 1.5 minutes, which will cause temporary loss of monitoring. If…
FDA · DeviceSpacelabs Healthcare, Inc.US: MN, TX, TN, SC, OK, NM, GA, PA, OH, IA, AL, CO, AR, FL, MO, ME, LA, IL,…Official notice → - US
Spacelabs Healthcare, Inc. recalls Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data.
Telemetry receiver systems may experience a Windows proxy Issue causing the system to shut down and restart (Offline displayed), lasting approximately 1 to 1.5 minutes, which will cause temporary loss of monitoring. If…
FDA · DeviceSpacelabs Healthcare, Inc.US: OK, MN, IA, SC, NE, MI, NY, KY, GA, MO, MT, LA, WA, SD, CO, PA, WY, TX,…Official notice → - 2024-12-25
- US
Spacelabs Healthcare, Ltd. recalls Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory…
Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter recorder. The physical serial number label on the device might not match the serial number programmed into the…
FDA · DeviceSpacelabs Healthcare, Ltd.U.S.: AR, CA, CO, DE, FL, FA, LA, MA, MI, MN, MT, NC, NE, NU OH, OR, PA,…Official notice → - 2023-05-10
- US
Spacelabs Healthcare, Inc. recalls Ultraview SL (UVSL) Command Module, Model 91496
Command modules will display the following when parameter processing is suspended, depending on software version: 1) Older versions will have waveforms present with no alarms, 2) Newer versions have waveforms absent…
FDA · DeviceSpacelabs Healthcare, Inc.US Nationwide distribution in the states of SD, KY, MO, WA, OH, NC, CA, OR,…Official notice → - 2022-08-17
- US
Spacelabs Healthcare, Inc. recalls Xhibit Telemetry Receiver, Model: 96280
Software related alarm escalation defect occurs after approximately 25 days of continuous use. Technical alarm escalation for the following alarms, signal loss, all leads off, low battery, SpO2 sensor off, and signal…
FDA · DeviceSpacelabs Healthcare, Inc.Worldwide distribution - US Nationwide distribution in the states of NY, AR,…Official notice →