Recall Z-2586-2014 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Spacelabs Healthcare Inc
ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient monitor. Used in a hospital environment.
| Date | Sep 4, 2014 (initiated Jul 2, 2014) |
| Status | Terminated |
| Reason | The transmitter display and the Telemetry Central Station display may show a SpO2 value when the sensor is not connected to the patient or in certain sensor failed conditions. This is an expansion of recall Z-0871-2014 because additional serial numbers were identified as being part of this recall action as part of the firm's retrospective analysis of all recalls since 2011. |
| Root cause | Software design |
| Action | Spacelabs notified both consignees via email of the expanded recall July 2, 2014. A f/u letter was sent by overnight delivery to the single new consignee the same day. Spacelabs sent an announcement of the expanded recall to both consignees identified in the expanded recall August 25, 2014. A field service technician from Spacelabs will visit each consignee and upgrade the software as necessary. If you have any questions about this corrective action program, please contact SpaceLabs Healthcare at 1-800- 522-7025, and select 2 for Technical Support. |
| Quantity | 8 units |
| Distribution | US Distribution to TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121480 | ARIATELE TELEMETRY TRANSMITTER (96281) Spacelabs Healthcare, Jun 6, 2012 |