Recall Z-0690-2012 ยท DSI Detector And Alarm, Arrhythmia
Spacelabs Healthcare, Llc
Ultraview SL Command Module is the Spacelabs Multi-parameter Module. It is intended for use with the Patient Care Management 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. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System
| Date | Jan 11, 2012 (initiated Nov 3, 2011) |
| Status | Terminated |
| Reason | NIBP pump inside the Ultraview SL Command Module, Model 91496, became loose. The pump is suspended by the air hoses and electrical connections, but there can be enough movement to damage internal components and cause the module to fail. |
| Root cause | Process change control |
| Action | SpaceLabs Healthcare sent a Urgent Field Safety Notice dated November 28, 2011, return receipt requested to all US customers. The letter identified the product the problem and the action needed to be taken by customer. On December 6, 2011, SpaceLabs will send a customer letter (translated as necessary) will be emailed to all international subsidiaries and distributors of record. Records of notification will be maintained to ensure complete notification. Customers were instructed If you hear an unusual rattling noise, tag the module, set it aside and contact your Spacelabs field service engi |
| Quantity | 6722 units worldwide (3598 units in US and 3124 units outside US) |
| Distribution | Worldwide Distribution -- USA (nationwide) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103142 | SPACELABS MULTI-PARAMETER MODULE Spacelabs Healthcare, Inc., Mar 3, 2011 |