Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported August 17, 2022
Xhibit Telemetry Receiver, Model: 96280
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Spacelabs Healthcare, Inc. recalled Xhibit Telemetry Receiver, Model: 96280 - a moderate-severity action.
Xhibit Telemetry Receiver, Model: 96280 was recalled by Spacelabs Healthcare, Inc. in August 17, 2022. Reason: Software related alarm escalation defect occurs after approximately 25 days of continuous use. Technical alar…. Check the official notice for the remedy. Verify recall #Z-1513-2022 with the FDA Devices before acting.
The recall
Spacelabs Healthcare, Inc. issued this moderate-severity FDA Devices recall-Software related alarm escalation defect occurs after approximately 25 days of continuous use. Technical alar….
- Moderate
- severity level
- 529 units
- affected scope
- Class II
- classification
- August 17, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1513-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1513-2022) was formally reported on August 17, 2022, with the manufacturer initiating the action on May 31, 2022. It is classified under Moderate severity (Class II), with a current status of Ongoing. Spacelabs Healthcare, Inc. is listed as the recalling firm, operating out of Snoqualmie, WA. Federal records list the affected scope as 529.
The documented reason for this recall is: 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 in… Distribution data in the federal record shows the product reached: 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 countri…. 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.
Medical Devices recalls over time
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.
Affected scope
529
Related Recalls
6
3 from same agency
Product description
Xhibit Telemetry Receiver, Model: 96280
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1513-2022 |
| Date reported | August 17, 2022 |
| Date initiated | May 31, 2022 |
| Recalling firm | Spacelabs Healthcare, Inc. |
| Firm location | Snoqualmie, WA |
| Affected scope | 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… |
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.
- Check the recall number (Z-1513-2022) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
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.
Frequently Asked Questions
What product was recalled? ▼
Xhibit Telemetry Receiver, Model: 96280. Recalled by Spacelabs Healthcare, Inc.. Units affected: 529.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 17, 2022. Severity: Moderate. Recall number: Z-1513-2022.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1513-2022) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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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 August 17, 2022. 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.