Recall Z-2916-2011 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Spacelabs Healthcare, Llc
Vital Sign elance Monitor, Model 93300 Spacelabs Healthcare, Llc. A vital signs patient monitor with arrhythmia detection.
| Date | Aug 2, 2011 (initiated Jul 6, 2011) |
| Status | Terminated |
| Reason | Model 93300 Vital Signs Monitor may stop operating while in use, and when this occurs, the monitor may also fail to power ON. The resulting situation may cause a loss of monitoring for the patient. |
| Root cause | Process design |
| Action | Spacelabs Healthcare, Llc sent an "Urgent-Medical Device Correction" letter dated 18 July 2011 to all affected customers. The letter notified the customers of the problem and recommended customers make their staff aware. It also informed them a Field Service Engineer will contact them to check, and if necessary make adjustments. Customers can contact Spacelabs Healthcare at 800-522-7025 and select 2 for Technical Support or outside the U.S. at +86512-8717-1888, extension 304. |
| Quantity | 1970 units |
| Distribution | Worldwide Distribution: (USA) Nationwide distribution including the state of WI, and the countries of Puerto Rico, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Chile, China, Colombia, Cyprus, Dominican Republic, Ecuador, Egypt, El Salvador, France, Germany, Greece, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093501 | ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION Spacelabs Medical, Inc., Nov 24, 2009 |