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Terminated

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

FDA Recall Z-2586-2014 · Posted 2014-09-04

Recalling FirmSpacelabs Healthcare Inc
Recall StatusTerminated
Product CodeMHX
Date Initiated2014-07-02
Date Terminated2014-10-16
Product Quantity8 units

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.

Firm 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.

Root Cause

Software design

Distribution Pattern

US Distribution to TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K121480ARIATELE TELEMETRY TRANSMITTER (96281)Spacelabs Healthcare · 2012-06-06

Official Source

View FDA Recall →

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

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