Ultraview Digital Telemetry Transmitter, Model 90478 The Spacelabs Medical Digital Telemetry system provides continuous electrocardiographic (ECG) monitoring to detect ST segment changes, abnormal cardiac rhythms, including asystole, ventricular fibrillation and ventricular tachycardia.
FDA Recall Z-1652-2008 · Posted 2008-09-18
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Recalling FirmSpacelabs Healthcare, Incorporated
Recall StatusTerminated
Product CodeDSI
Date Initiated2008-07-18
Date Terminated2011-03-21
Product Quantity37,590
Reason for Recall
Telemetry Modules are failing to alarm for low heart rate and asystole.
Firm Action
On 07/18/08 Spacelabs Healthcare issued a "URGENT-MEDICAL DEVICE CORRECTION" letter, dated July 16, 2008, to all customers who received the Spacelabs Medical Telemetry Receiver-Model 90478. The letter states circumstances in which the alarm fails, how to test each module for high rate alarm prior to patient use and a temporary work around if the alarm failure exists.` Letters have a receipt acknowledgement to ensure each customer receives the letter. Spacelabs Technical Support will personally install the new software, version V3.05.07EN, in all Spacelabs Medical Telemetry Receivers Model 90478. Technical Support will also be responsible for responding to customer technical questions and ensuring each customer is upgraded regarding this medical device recall. For assistance contact SpaceLabs Medical at 1-425-657-7200.
Root Cause
Software design
Distribution Pattern
Nationwide and Internationally
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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