Z-1513-2022Class II

Xhibit Telemetry Receiver, Model: 96280

Name: Z-1513-2022 Xhibit Telemetry Receiver, Model: 96280
Creator: Spacelabs Healthcare, Inc.
Published: 2022-05-31
License: https://open.fda.gov/license/

GE Healthcare / initiated 2022-05-31 / Open, Classified / root cause: software

FDA source

Spacelabs Healthcare, Inc. began a recall of Xhibit Telemetry Receiver, Model: 96280 on 2022-05-31. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1513-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-05-31
Posted: 2022-08-11
Recalling firm: GE Healthcare
Product: Xhibit Telemetry Receiver, Model: 96280
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software Design Change
Action: 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
Quantity in commerce: 529
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 codes and lots: 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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Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1513-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1513-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-17	2022-08-11

Product code MHX

K141156Class IISpacelabs Healthcare Telemetry ReceiverSpacelabs Healthcare / cleared 2014-09-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)