Recall Z-2336-2008 ยท DSI Detector And Alarm, Arrhythmia
Spacelabs Healthcare, Incorporated
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.
| Date | Sep 25, 2008 (initiated Jul 17, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| 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 pers |
| Quantity | 2,055 transmitters |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.