ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2… recallZ-2586-2014 · Spacelabs Healthcare Inc · initiated Jul 2, 2014
Class II Terminated All recalls posted in September 2014
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
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.
FDA root cause category: Software design
What the company is doing
Spacelabs notified both consignees via email of the expanded recall July 2, 2014. A f/u letter was sent by overnight delivery to the single new consignee the same day. Spacelabs sent an announcement of the expanded recall to both consignees identified in the expanded recall August 25, 2014. A field service technician from Spacelabs will visit each consignee and upgrade the software as necessary. If you have any questions about this corrective action program, please contact SpaceLabs Healthcare at 1-800- 522-7025, and select 2 for Technical Support.
Recall details
- Recall number
- Z-2586-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jul 2, 2014
- Posted by the FDA
- Sep 4, 2014
- Recalling firm
- Spacelabs Healthcare Inc
- Quantity
- 8 units
- Product code
- MHX
- FDA submissions
- K121480
- Distribution
- US Distribution to TX.
Product description
ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient monitor. Used in a hospital environment.
Code information (models, lots, serial numbers)
Serial numbers: 6281-002500, 6281-002501, 6281-002659, 6281-002661, 6281-002662, 6281-002663, 6281-002664, and 6281-003056. Model 96281, with SpO2 Option C.
Other devices under the same FDA submission
1 device cleared under K121480 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- AriaTele 96281Spacelabs Healthcare (Washington), Inc · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)3 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 18, 2026. Text above is shown as published by the FDA.
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