Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.

FDA Recall Z-0871-2014 · Posted 2014-01-30

Recalling FirmSpacelabs Healthcare, Llc
Recall StatusTerminated
Product CodeMHX
Date Initiated2013-12-19
Date Terminated2014-06-12
Product Quantity1057 units (988 in the US and 69 outside of the US).

Reason for Recall

The AriaTele Model 96281 with SpO2 monitoring Option C is recalled because the AriaTele (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.

Firm Action

On January 6, 2014, Spacelabs sent an "URGENT - MEDICAL DEVICE CORRECTION Spacelabs Healthcare AriaTele Model 96281 with SpO2 Option C" letter, dated 03 January 2014 to US consignees. On January 9, 2014, Spacelabs e-mailed the "URGENT - MEDICAL DEVICE CORRECTION Spacelabs Healthcare AriaTele Model 96281 with SpO2 Option C" letter (translated as necessary), dated 03 January 2014, to foreign consignees. The letter described product, problem and actions to be taken. The Consignees where instructed to follow the "Advise on what action the clinician takes" on the letter. Spacelabs Healthcare will contact you at the earliest possible date to schedule a convenient tie for Spacelabs to correct all of your facility's affected transmitters (software update) at no cost. 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

Worldwide Distribution: US (nationwide) including states of: AZ, CA, FL, GA, IA, IL, LA, MA, ME, MI, MO, MS, NY, PA, SC, TN, TX, VA, and Puerto Rico; and Internationally to: Canada, Chile, and Panama.

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.

↑