FDA Device recall Z-2261-2020
Xhibit Central, Model No. 96102 - Product Usage: intended use is to provide clinicians with central monitoring of adult, pediatric and neon…
- FDA Device
- Class II
- terminated
- Published 2020-06-10
On 2020-06-10 the FDA classified a Class II recall of Xhibit Central, Model No. 96102 - Product Usage: intended use is to provide clinicians with central monitoring of adult, pediatric and neon… by Spacelabs Healthcare, citing 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 co….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2261-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-08-30 |
| Published | 2020-06-10 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Spacelabs Healthcare |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | Model No. 96102 Xhibit Central; Software Versions: 1.3.1, 1.3.2, 1.3.3 and 1.3.4; UDI: 10841522100345 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Other recalls by Spacelabs Healthcare
- Brand Name: Xhibit Product Name: Xhibit Central Station Model/Catalog Number: 96102 Software Version: N/A Product Description: The Spacelab…
FDA Device · Class II · 2026-08-19 · Spacelabs Healthcare - Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software Version: N/A Product…
FDA Device · Class II · 2026-05-13 · Spacelabs Healthcare - Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Device · Class II · 2026-04-15 · Spacelabs Healthcare - Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version: 11.6.0 Product Description: Cardiology In…
FDA Device · Class II · 2025-11-12 · Spacelabs Healthcare - Brand Name: Branding is not applied to this product
FDA Device · Class II · 2025-10-22 · Spacelabs Healthcare
All Spacelabs Healthcare recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2261-2020%22
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