FDA Medical Device Recalls (openFDA)
Spacelabs Healthcare, Inc.: Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.
- Recall number
- Z-0810-2025
- Recalling firm
- Spacelabs Healthcare, Inc.
- Product
- Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.
- Status
- Open, Classified
- Initiated
- 2024-11-25
- Posted
- 2025-01-07
- Terminated
- not on file
- Reason
- Telemetry receivers with affected software versions may experience unsolicited system 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 and necessary clinical intervention could be delayed.
- Root cause
- Software change control
- Action
- On 11/25/2024, correction notices were emailed to customers who were asked to do the following: Firm will contact you at the earliest possible date to schedule a convenient time to update affected devices to software version 1.4.2 for XTR systems which addresses this defect. You can also contact GTS to have an FSE paged out for discussing upgrade schedule: 1-800-522-7025 and select 2 for Technical Support. Complete and submit the customer acknowledgement form: https://spacelabshealthcare.com/support/recall-reply-form/recall-reply-form-xtr-15-nov-2024/ For additional information or technical assistance, or to report an adverse event, contact: Technical Support: 1-800-522-7025 and select 2
- Quantity
- 434
- Distribution
- US: MN, TX, TN, SC, OK, NM, GA, PA, OH, IA, AL, CO, AR, FL, MO, ME, LA, IL, WA, MA, WI, OR, MS, ID, NY, KS, PR. OUS: Canada, Taiwan, Czech Republic, France, Greece, Italy, Kuwait, Philippines, Poland.
- Lot, serial or model codes
- Software Versions: 1.4.0 and 1.4.1. UDI-DI: 10841522107177, 10841522100246
- 510(k) numbers
- ["K141156"]
- 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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