Recall Z-2343-2008 ยท DSI Detector And Alarm, Arrhythmia
Spacelabs Healthcare, Incorporated
Ultraview SL Command Module, Model 91496 The product is intended for use with the Patient Care Monitoring System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include cardiac activity, respiration, invasive and noninvasive pressu
| Date | Sep 19, 2008 (initiated Jul 22, 2008) |
| Status | Terminated |
| Reason | Potential for module to fail to obtain a NIBP reading on hypertension patients. |
| Root cause | Process control |
| Action | On July 22, 2008 an "Urgent MEDICAL DEVICE CORRECTION" letter was mailed to all the firm's customers. The letter states the problem at hand, when the problem would likely to occur and instructions of a way to mitigate the risk, until the modules can be recalibrated . The firm's Customer Connectivity Center will confirm all affected customers have been notified. Spacelabs Technical Support will be recalibrating all modules personally and ensuring all corrections have been applied to all affected customers of record. Contact Spacelabs Healthcare at 1-800-522-7025 for assistance. |
| Quantity | 22,079 |
| Distribution | The product is distributed nationwide and internationally to medical facilities. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K972502 | SPACELABS MEDICAL INTEGRATED MULTIPARAMETER MODULE 90496 Spacelabs Medical, Inc., May 28, 1998 |