Spacelabs Telemetry Receiver Recall Due to Loss of Patient Monitoring
Spacelabs Healthcare is recalling 12 Xhibit Telemetry Receiver systems because they may drop off the central station, causing a loss of patient monitoring.
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: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (patient monitor) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Spacelabs Healthcare Inc is recalling 12 units of the Xhibit Telemetry Receiver, Model 96280, software version 1.1. These physiological patient monitors are intended to provide adult, pediatric, and neonatal patient data, including physiological waveforms, cardiac arrhythmia, and ST data, to the Spacelabs Healthcare monitoring system.
The recall was initiated after Spacelabs received multiple complaints reporting that telemetry beds were dropping off the Spacelabs Central Station. This malfunction results in a loss of monitoring for connected patients.
The affected units were distributed in the United States to Virginia, New Jersey, Michigan, and Georgia, as well as internationally to France. The specific serial numbers for the 12 affected systems are: 6280-000359, 6280-000340, 6280-000336, 6280-000503, 6280-000502, 6280-000500, 6280-000496, 6280-000495, 6280-000327, 6280-000260, 6280-000566, and 6280-000290. Healthcare facilities should contact Spacelabs Healthcare for instructions on how to address this issue.
The recalled product
- Product
- Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1, physiological patient monitor (with arrhythmia detection or alarms) The Spacelabs Healthcare Telemetry Receiver, Model 96280, is intended to provide the Spacelabs Healthcare monitoring system…
- Manufacturer
- Spacelabs Healthcare Inc
- Category
- Medical Device — Patient Monitor
- Hazard
- Affected units
- 12
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 (12)
- Serial numbers: 6280-000359
- 6280-000340
- 6280-000336
- 6280-000503
- 6280-000502
- 6280-000500
- 6280-000496
- 6280-000495
- 6280-000327
- 6280-000260
- 6280-000566
- 6280-000290
Distribution
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