FDA Medical Device Recalls (openFDA)
Spacelabs Healthcare, Inc.: 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.
- Recall number
- Z-2261-2020
- Recalling firm
- Spacelabs Healthcare, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2019-08-30
- Posted
- not on file
- Terminated
- 2024-04-18
- 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.
- Root cause
- Software Manufacturing/Software Deployment
- Action
- Urgent Medical Device Correction letters were sent to U.S. customers on August 30, 2019 via priority service, and to foreign customers via email on September 6, 2019. The letter informed customers of the conditions under which alarm audio may be lost, and actions the customer /user can take to minimize risk to patients or users. Customers were requested to weigh the benefits versus the risks when deciding whether or not to continue to use Xhibit Central with software versions 1.3.1, 1.3.2, 1.3.3, and 1.3.4. Customers experiencing a loss of audio were informed that a complete reboot of the Xhibit Central will return the device to normal operation. Customers were requested to circulate this notification to all persons affected by the information it contains. Customers were also informed that the manufacturer would contact them to schedule a time for Spacelabs to update their Xhibit Central software. Customers with questions, requiring information, or technical assistance may contact the Technical Support group at Spacelabs Healthcare, Inc. at 1-800-522-7025 and select 2 for Technical Support.
- Quantity
- 2197 units
- Distribution
- Worldwide distribution - US Nationwide distribution including in the 40 states and Puerto Rico, and multiple countries including Canada.
- Lot, serial or model codes
- Model No. 96102 Xhibit Central; Software Versions: 1.3.1, 1.3.2, 1.3.3 and 1.3.4; UDI: 10841522100345
- 510(k) numbers
- ["K122146"]
- PMA numbers
- not on file
- Product code
- MHX
- Firm FEI
- 3010157426
- Firm city
- Snoqualmie
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28