Z-2261-2020 Class II Terminated
FDA device recall Z-2261-2020 was initiated by Spacelabs Healthcare, Inc. on August 30, 2019 and is designated Class II. Reason for recall: The firm received reports of loss of audio alarm after a power failure or cable disconnection. The loss of audio for a telemetry patient could delay the recognition of an alarm condition. The recall status is terminated (terminated April 18, 2024). Affected quantity: 2197 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 10, 2020
- Initiation Date
- August 30, 2019
- Termination Date
- April 18, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2197 units
Product Description
Xhibit Central, Model No. 96102 - Product Usage: intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.
Reason for Recall
The firm received reports of loss of audio alarm after a power failure or cable disconnection. The loss of audio for a telemetry patient could delay the recognition of an alarm condition.
Distribution Pattern
Worldwide distribution - US Nationwide distribution including in the 40 states and Puerto Rico, and multiple countries including Canada.
Code Information
Model No. 96102 Xhibit Central; Software Versions: 1.3.1, 1.3.2, 1.3.3 and 1.3.4; UDI: 10841522100345