Xhibit Telemetry Receiver Model 96280 alarm escalation software defect
Xhibit Telemetry Receiver Model 96280 units fail to escalate critical alarms after approximately 25 days of continuous use, including signal loss, low battery, and SpO2 sensor issues. Caregivers may not be aware of device failures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with documented software defect causing failure in critical alarm escalation during patient monitoring. No illnesses or injuries reported. Meets rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Spacelabs Healthcare is recalling the Xhibit Telemetry Receiver Model 96280, a patient monitoring device, due to a software defect affecting alarm escalation. The defect occurs after approximately 25 days of continuous use.
When the device operates for approximately 25 days continuously, it fails to escalate certain technical alarms as specified: signal loss, all leads off, low battery, SpO2 sensor off, and signal interference. Because alarm escalation does not occur, caregivers may not respond to the initial technical alarm and may not be aware of the continuing technical failure in the device's patient monitoring function.
Approximately 529 units with software version 1.4.0 have been distributed worldwide, including throughout the United States and Canada. Affected serial numbers are identified in the FDA recall notice.
The recalled product
- Product
- Xhibit Telemetry Receiver, Model: 96280
- Manufacturer
- Spacelabs Healthcare, Inc.
- Affected units
- 529
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI-DI: 10841522100246
- Software version 1.4.0. Serial Numbers: 6280-001538
- 6280-000590
- 6280-000589
- 6280-000339
- 9280-000711
- 6280-001103
- 6280-001102
- 6280-001469
- 6280-001467
- 6280-001686
- 6280-001399
- 6280-001323
- 6280-000457
- 6280-000456
- 6280-000455
- 6280-000440
- 6280-000439
- 6280-000438
- 6280-000429
Distribution
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