Xhibit Telemetry Receiver, Model: 96280 recallZ-1513-2022 · Spacelabs Healthcare, Inc. · initiated May 31, 2022

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Spacelabs Healthcare, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Software related alarm escalation defect occurs after approximately 25 days of continuous use. Technical alarm escalation for the following alarms, signal loss, all leads off, low battery, SpO2 sensor off, and signal interference, does not occur in the telemetry receiver as specified. Caregiver may not respond to the initial technical alarm and may not be aware of the continuing technical failure.

FDA root cause category: Software Design Change

What the company is doing

On 05/31/22, correction notices were mailed to customers who were asked to take the following actions that can be taken to minimize risk to patients or users: Weigh the benefits versus the risks when deciding whether to continue to use the alarm escalation feature within XTR 1.4. Suggestions from Spacelabs to mitigate the risk: - Set the priority to the same level as the escalation max on the product. This will ensure that the highest priority alarm is triggered for the technical alarm. - Do not run the XTR 1.4 for more than 24 days consecutively. Restarting the XTR after 24 days will mitigate the issue for another 24 days. - The recalling firm is working on a 1.4.1 release of XTR which will address this defect. For additional information or technical assistance, please contact: Technical Support, 1-800-522-7025 and select 2

Recall details

Recall number: Z-1513-2022
Status: Open, Classified
Initiated by the company: May 31, 2022
Recalling firm: Spacelabs Healthcare, Inc.
Quantity: 529
Product code: MHX
FDA submissions: K141156
Distribution: Worldwide distribution - US Nationwide distribution in the states of NY, AR, CO, FL, NJ, AL, KY, TN, SC, WA, OK, MN, PA, GA, VA, CA, OH, IA, KS, MI, IN, TX, MT, MO, ME, LA, IL, SD, MA, OR, ID, MD, AZ, AK and the countries of MB, ON, FR, QC, BC, IS, CT, RM.

Product description

Xhibit Telemetry Receiver, Model: 96280

Code information (models, lots, serial numbers)

Show the full code information (7k characters)

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, 6280-000476, 6280-000475, 6280-001693, 6280-000703, 6280-000702, 6280-000701, 6280-000700, 6280-000314, 6280-000258, 6280-000157, 6280-001223, 6280-001222, 6280-001221, 6280-001220, 6280-001219, 6280-001218, 6280-001217, 6280-001216, 6280-001215, 6280-001214, 6280-001207, 6280-001127, 6280-001125, 6280-001124, 6280-001123, 6280-001056, 6280-001055, 6280-001054, 6280-001053, 6280-001052, 6280-001051, 6280-001050, 6280-001288, 6280-001287, 6280-001490, 6280-001692, 6280-000588, 6280-000517, 6280-000516, 6280-000515, 6280-001668, 6280-000206, 6280-000162, 6280-000210, 6280-000663, 6280-000377, 6280-001589, 6280-001385, 6280-001384, 6280-001382, 6280-001405, 6280-000594, 6280-000593, 6280-000592, 6280-000596, 6280-000274, 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6280-000173, 6280-000172, 6280-000170, 6280-000168, 6280-000167, 6280-000077, 6280-000598, 6280-000355, 6280-000344, 6280-000341, 6280-000338, 6280-000468, 6280-000423, 6280-000478, 6280-000477, 6280-000454, 6280-000428, 6280-000261, 6280-001614, 6280-001642, 6280-001641, 6280-001640, 6280-001639, 6280-001638, 6280-001637, 6280-001636, 6280-001635, 6280-001634, 6280-001633, 6280-001632, 6280-001631, 6280-001630, 6280-001629, 6280-001913, 6280-000138, 6280-000437, 6280-000436, 6280-000177, 6280-000176, 6280-000337, 6280-001857, 6280-001853, 6280-001749, 6280-001359, 6280-001160, 6280-001159, 6280-001158, 6280-001157, 6280-001156, 6280-001154, 6280-001132, 6280-001112, 6280-001109, 6280-000991, 6280-000983, 6280-001189, 6280-001188, 6280-001205, 6280-001204, 6280-001203, 6280-001202, 6280-001200, 6280-001194, 6280-001193, 6280-001184, 6280-001166, 6280-000358, 6280-000357, 6280-000345, 6280-000432, 6280-000431, 6280-000811, 6280-000693, 6280-000690, 6280-000929, 6280-001063, 6280-001062, 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6280-001820, 6280-001805, 6280-001444, 6280-001225, 6280-000850, 6280-000725, 6280-000694, 6280-000553, 6280-000549, 6280-000548, 6280-000330, 6280-000317, 6280-000188, 6280-000182, 6280-000290, 6280-001818, 6280-001765, 6280-001602, 6280-001601, 6280-001450, 6280-001449, 6280-001377, 6280-001376, 6280-001178, 6280-001049, 6280-000796, 6280-000743, 6280-000491, 6280-000356, 6280-000295, 6280-000293, 6280-000292, 6280-000291, 6280-000231, 6280-000196, 6280-000061, 6280-000060, 6280-000473, 6280-000232, 6280-000062, 6280-001319, 6280-001313, 6280-000384, 6280-000199, 6280-000198, 6280-000065, 6280-000064, 6280-000237, 6280-000406, 6280-000401, 6280-000362, 6280-000270, 6280-000400, 6280-001245, 6280-001101, 6280-000873, 6280-000871, 6280-000870, 6280-000861, 6280-000860, 6280-000815, 6280-000554, 6280-000527, 6280-000499, 6280-000416, 6280-000371, 6280-000197, 6280-000523, 6280-000063

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Xhibit Telemetry Receiver
Spacelabs Healthcare (Washington), Inc · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
3 recalls30 reports

Other devices under the same FDA submission

1 device cleared under K141156 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

XTR 96280
Spacelabs Healthcare (Washington), Inc · SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS
2 recalls0 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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