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Open, Classified

Xhibit Telemetry Receiver, Model: 96280

FDA Recall Z-1513-2022 · Posted None

Recalling FirmSpacelabs Healthcare, Inc.
Recall StatusOpen, Classified
Product CodeMHX
Date Initiated2022-05-31
Product Quantity529

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.

Firm 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

Root Cause

Software Design Change

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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