FDA Medical Device Recalls (openFDA)
Spacelabs Healthcare Inc: ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient monitor. Used in a hospital environment.
- Recall number
- Z-2586-2014
- Recalling firm
- Spacelabs Healthcare Inc
- Product
- ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient monitor. Used in a hospital environment.
- Status
- Terminated
- Initiated
- 2014-07-02
- Posted
- 2014-09-04
- Terminated
- 2014-10-16
- Reason
- 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.
- Root cause
- Software design
- Action
- 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.
- Quantity
- 8 units
- Distribution
- US Distribution to TX.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K121480"]
- PMA numbers
- not on file
- Product code
- MHX
- Firm FEI
- 3010157426
- Firm city
- Snoqualmie
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28