Home / Recalls / Spacelabs Healthcare, Inc. / Z-0809-2025

Z-0809-2025 Class II Ongoing

Recalled by Spacelabs Healthcare, Inc. — Snoqualmie, WA

FDA device recall Z-0809-2025 was initiated by Spacelabs Healthcare, Inc. on November 25, 2024 and is designated Class II. Reason for recall: 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… The recall status is ongoing. Affected quantity: 2265.

Recall Details

Product Type
Devices
Report Date
January 15, 2025
Initiation Date
November 25, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2265

Product Description

Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data.

Reason for Recall

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 a clinical event occurred during this period, staff may not detect until the system restarts; necessary clinical intervention could be delayed.

Distribution Pattern

US: OK, MN, IA, SC, NE, MI, NY, KY, GA, MO, MT, LA, WA, SD, CO, PA, WY, TX, ID, NJ, FL, OH, MS, OR, AK, IL, AR, KS, AL, TN, WI, VA, NM, CA, IN, RI, NV, MA, NC, ME, CT, AZ, MD, PR. OUS: Kuwait, Australia, Canada, Roumanie, Greece, Philippines, Spain, Italy, Hong Kong, Switzerland, Panama, Taiwan, Netherlands, Malaysia, Poland, Mexico, United Kingdom, Saudi Arabia, France, Czech Republic

Code Information

Service Manuals P/N 070-2409-07 and Prior. UDI-DI: 10841522107177, 10841522100246

Other recalls by Spacelabs Healthcare, Inc.

  • Z-2052-2026 Class II — Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Modu (March 26, 2026)
  • Z-1793-2026 Class II — Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor (February 27, 2026)
  • Z-0416-2026 Class II — Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 9281 (September 16, 2025)
  • Z-0169-2026 Class II — Brand Name: Branding is not applied to this product. Product Name: DVI display (September 5, 2025)
  • Z-0167-2026 Class II — Brand Name: Branding is not applied to this product. Product Name: DVI display (September 5, 2025)
  • Z-0168-2026 Class II — Brand Name: Branding is not applied to this product. Product Name: DVI display (September 5, 2025)
  • Z-0685-2025 Class II — Eclipse Mini REF 98900 The Eclipse MINI Model 98900 is a portable non-invasiv (November 25, 2024)
  • Z-0684-2025 Class II — Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Ho (November 25, 2024)
  • Z-0810-2025 Class II — Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monit (November 25, 2024)
  • Z-1503-2023 Class II — Ultraview SL (UVSL) Command Module, Model 91496 (April 12, 2023)

FDA data resources