Home / Recalls / Spacelabs Healthcare, Ltd. / Z-0684-2025

Z-0684-2025 Class II Ongoing

Recalled by Spacelabs Healthcare, Ltd. — Hertford

FDA device recall Z-0684-2025 was initiated by Spacelabs Healthcare, Ltd. on November 25, 2024 and is designated Class II. Reason for recall: 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 p… The recall status is ongoing. Affected quantity: 13,202 devices.

Recall Details

Product Type
Devices
Report Date
December 25, 2024
Initiation Date
November 25, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
13,202 devices

Product Description

Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory electrocardiogram.

Reason for Recall

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 device.

Distribution Pattern

U.S.: AR, CA, CO, DE, FL, FA, LA, MA, MI, MN, MT, NC, NE, NU OH, OR, PA, Puerto Rico, TN, TX, UT, VA, WA, and WI. O.U.S.: Argentina Denmark Kuwait Serbia Australia Dominican Republic Lebanon Singapore Austria Ecuador Lithuania Spain Belgium El Salvador Martinique Sweden Benin France Mexico Switzerland Bolivia Germany Netherlands Taiwan Brazil Greece Oman Trinidad and Tobago Brunei Darussalam Guatemala Panama Turkey Canada Honduras Peru United Arab Emirates Chile Hong Kong Poland United Kingdom China Iceland Portugal Columbia India Venezuela Congo Ireland Qatar Viet Nam Costa Rica Israel Republic of Macedonia Croatia Italy Roumanie Czech Republic Korea, Republic of Saudi Arabia

Code Information

Model Number: 98700 UDI-DI code: 10841522128851 Serial Numbers: All serial numbers manufactured between April 2021 to November 2024. Serial Numbers pending.

Other recalls by Spacelabs Healthcare, Ltd.

  • 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-0810-2025 Class II — Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monit (November 25, 2024)
  • Z-0809-2025 Class II — Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provi (November 25, 2024)
  • Z-1503-2023 Class II — Ultraview SL (UVSL) Command Module, Model 91496 (April 12, 2023)

FDA data resources