Recall Z-2382-2012 ยท DSI Detector And Alarm, Arrhythmia
Spacelabs Healthcare, Llc
Ultraview SL 91493 Integrated Module Housing. PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter module determines (a) when an alarm condition is violated; (b) the alarm priority (i.e. high, medium or low); (c) alarm limits; and (d) when to generate and terminate alarms. PCIS patient monitors are
| Date | Sep 14, 2012 (initiated Aug 27, 2012) |
| Status | Terminated |
| Reason | There is a potential failure of the Integrated Module Housing causing the patient module parameters to drop off the monitor display or the patient module will fail to sign on when inserted into the housing. |
| Root cause | Mixed-up of materials/components |
| Action | Spacelabs Healthcare sent an "URGENT- MEDICAL DEVICE CORRECTION" letter dated August 27, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 1-800-522-7025 and select 2 for assistance regarding this recall. |
| Quantity | 527 units total; 350 US and 177 International |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K842616 | SPACELABS ALPHA PC PATIENT COMPUTER Spacelabs, Inc., Oct 18, 1984 |