Ultraview Digital Telemetry Transmitter, Model 91341-09 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-2336-2008 · Posted 2008-09-25
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Recalling FirmSpacelabs Healthcare, Incorporated
Recall StatusTerminated
Product CodeDSI
Date Initiated2008-07-17
Date Terminated2011-02-16
Product Quantity2,055 transmitters
Reason for Recall
During battery insertion there is potential for patient waveforms to move to an open receiver module or to an occupied receiver causing the intermittent inappropriate monitoring of both patients for several minutes.
Firm Action
On 07/17/08 the firm issued a "URGENT - MEDICAL DEVICE CORRECTION" letter to their customers who received the Spacelabs Medical 1400 MHz Telemetry System - Model 91341-09. The letter states the circumstances in which the device malfunctions, instructions for staff to confirm at the time of the battery insertion that the data is appearing and to remove it from service if information is not appearing. Letters will be sent with a return receipt acknowledging each customer receives the Medical Device Correction letter. Spacelabs Technical Support will respond to all technical questions and personally upgrade all switches with resisters. Contact Spacelabs Medical at 1-800-522-7025 for assistance.
Root Cause
Device Design
Distribution Pattern
Nationwide
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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