Severity
Moderate
FDA Devices recall · Reported October 5, 2016
The firm received multiple reports of Xhibit Telemetry System going offline or locking up. In addition, short-duration asystole alarms may not display an audio and visual alarm as…
Spacelabs Healthcare Inc recalled Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280. Xhibit Telemetry Rece… - a moderate-severity action.
Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280. Xhibit Telemetry Rece… was recalled by Spacelabs Healthcare Inc in October 5, 2016. Reason: The firm received multiple reports of Xhibit Telemetry System going offline or locking up. In addition, short…. Check the official notice for the remedy. Verify recall #Z-2886-2016 with the FDA Devices before acting.
The recall
Spacelabs Healthcare Inc issued this moderate-severity FDA Devices recall-The firm received multiple reports of Xhibit Telemetry System going offline or locking up. In addition, short….
Sourced from official FDA Devices enforcement records. Verify recall #Z-2886-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2886-2016) was formally reported on October 5, 2016, with the manufacturer initiating the action on August 25, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Spacelabs Healthcare Inc is listed as the recalling firm, operating out of Snoqualmie, WA. Federal records list the affected scope as 316 XTR units total (248 units in the US and 68 units outside US).
The documented reason for this recall is: The firm received multiple reports of Xhibit Telemetry System going offline or locking up. In addition, short-duration asystole alarms may not display an audio and visual alarm as reported from a single Canadian hospita… Distribution data in the federal record shows the product reached: Worldwide distribution. US nationwide including Puerto Rico, Australia, Canada, China, France, Germany, Ireland, Italy, Netherlands, Philippines, Poland, Romania, Switzerland, and United Kingdom.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
316 XTR units total (248 units in the US and 68 units outside US)
Related Recalls
6
3 from same agency
Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital signs.
The firm received multiple reports of Xhibit Telemetry System going offline or locking up. In addition, short-duration asystole alarms may not display an audio and visual alarm as reported from a single Canadian hospital.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2886-2016 |
| Date reported | October 5, 2016 |
| Date initiated | August 25, 2016 |
| Recalling firm | Spacelabs Healthcare Inc |
| Firm location | Snoqualmie, WA |
| Affected scope | 316 XTR units total (248 units in the US and 68 units outside US) |
| Distribution | Worldwide distribution. US nationwide including Puerto Rico, Australia, Canada, China, France, Germany, Ireland, Italy, Netherlands, Philippines, Poland, Romania, Switzerland, and United Kingdom. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 5, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.