PlainRecalls
ModerateClass IITerminated

FDA Devices recall · Reported September 10, 2014

ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient monitor. Used in a hospital environment.

The transmitter display and the Telemetry Central Station display may show a SpO2 value when the sensor is not connected to the patient or in certain sensor failed conditions. …

Recall #
Z-2586-2014
Affected scope
8 units
Initiated
July 2, 2014
Compiled from official public sources by the editorial team.
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Spacelabs Healthcare Inc recalled ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient m… - a moderate-severity action.

ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient m… was recalled by Spacelabs Healthcare Inc in September 10, 2014. Reason: The transmitter display and the Telemetry Central Station display may show a SpO2 value when the sensor is no…. Check the official notice for the remedy. Verify recall #Z-2586-2014 with the FDA Devices before acting.

The recall

Spacelabs Healthcare Inc issued this moderate-severity FDA Devices recall-The transmitter display and the Telemetry Central Station display may show a SpO2 value when the sensor is no….

Moderate
severity level
8 units
affected scope
Class II
classification
September 10, 2014
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-2586-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-2586-2014) was formally reported on September 10, 2014, with the manufacturer initiating the action on July 2, 2014. 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 8 units.

The documented reason for this recall is: The transmitter display and the Telemetry Central Station display may show a SpO2 value when the sensor is not connected to the patient or in certain sensor failed conditions. This is an expansion of recall Z-0871-20… Distribution data in the federal record shows the product reached: US Distribution to TX.. 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

-1,00001,0002,0003,0004,000 20052008201120142017202020232026 1,248
Severity2487872426High severity (most serious)Moderate severityLow severity
Where this recall sits in the database

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

8 units

Related Recalls

6

3 from same agency

Product description

ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient monitor. Used in a hospital environment.

Reason for recall

The transmitter display and the Telemetry Central Station display may show a SpO2 value when the sensor is not connected to the patient or in certain sensor failed conditions. This is an expansion of recall Z-0871-2014 because additional serial numbers were identified as being part of this recall action as part of the firm's retrospective analysis of all recalls since 2011.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number Z-2586-2014
Date reported September 10, 2014
Date initiated July 2, 2014
Recalling firm Spacelabs Healthcare Inc
Firm location Snoqualmie, WA
Affected scope 8 units
Distribution US Distribution to TX.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

8 units units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall
Multi-state (10K – 100K units) -
Large-scale (100K – 1M units) -
Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (Z-2586-2014) 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?
ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient monitor. Used in a hospital environment.. Recalled by Spacelabs Healthcare Inc. Units affected: 8 units.
Why was this product recalled?
The transmitter display and the Telemetry Central Station display may show a SpO2 value when the sensor is not connected to the patient or in certain sensor failed conditions. This is an expansion of recall Z-0871-2014 because additional serial numbers were identified as being part of this recall action as part of the firm's retrospective analysis of all recalls since 2011.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 10, 2014. Severity: Moderate. Recall number: Z-2586-2014.
Where was the recalled product distributed?
Distribution: US Distribution to TX..
How do I check if my product is affected by a recall?
Check the product description and recall number (Z-2586-2014) 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 September 10, 2014. 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.