Agency classClass IIOur severity:High FDA (Devices)·Z-1502-2016·Announced 2016-04-27

Spacelabs Xhibit Telemetry Receiver Recall for Signal Loss

Spacelabs Healthcare is recalling Xhibit Telemetry Receivers due to frequent signal loss that may cause offline errors on central monitors.

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 the loss of patient physiological data, which poses a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.

Plain-English summary

Spacelabs Healthcare Inc is recalling the Xhibit Telemetry Receiver (XTR), Model 96280, and associated Printed Circuit Board Assemblies (PCBAs). The recall involves 217 XTR units and 531 PCBAs, with 164 XTRs and 425 PCBAs distributed in the United States and 53 XTRs and 106 PCBAs distributed internationally.

The recall is being conducted because of reports of an abnormally high frequency of squelch events, which indicates a loss of the telemetry data signal. In some cases, the Xhibit Central Monitor displayed an 'Xhibit Offline' error message for all patients being monitored. The affected units were distributed in 17 US states and eight countries, including Australia, Canada, China, France, the Netherlands, the Philippines, Romania, and the United Kingdom.

Healthcare facilities should identify affected units by checking the serial numbers of the XTRs or the part numbers of the PCBAs listed in the official recall notice. Affected PCBAs do not have serial numbers. Users should contact Spacelabs Healthcare for instructions on how to resolve the issue.

The recalled product

Product: The Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280 is used to transmit patient(s) physiological measurements and data to a monitor.
Manufacturer: Spacelabs Healthcare Inc
Category: Medical Device — Patient Monitoring
Hazard: signal-loss
data-interruption

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)

UPGRADE
PCBA
QUAD RCVR
T BAND
96280
050-0758-00 REPLACEMENT KIT
Q BAND
050-0759-00 REPLACEMENT KIT
050-0760-00 REPLACEMENT KIT
V BAND
050-0758-00-X REPLACEMENT KIT
96280 EXCHANGE
050-0759-00-X REPLACEMENT KIT
050-0760-00-X REPLACEMENT KIT
050-0519-00 CM KIT
ET
600 MHZ-1400MHZ
NA
050-0532-00 CM KIT
400MHZ-600MHZ

Distribution

Distributed in 17 states:

Same manufacturer · Spacelabs Healthcare Inc

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Same hazard · signal loss