Recall Z-0808-2014 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
GE Healthcare, LLC
GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and monitoring system, to another. K900540: TRAM modules are intended for use under the direct supervision of a licensed healthc
| Date | Jan 22, 2014 (initiated Dec 5, 2013) |
| Status | Terminated |
| Reason | Intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG cable connector on the DASH, PDM, and/or Tram Module. May result in reduced ECG, Respiration and arrhythmia detection performance. |
| Root cause | Pending |
| Action | GE Healthcare sent an Urgent Medical Device Correction letter dated December 5, 2013, to all affected customers. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. Customers with questions were instructed to contact Technical Support at 1-800-558-7044. For questions regarding this recall call 262-513-4122. |
| Quantity | 1,948 (1,834 US; 114 OUS) |
| Distribution | Worldwide Distribution: US (nationwide) including DC and PR except SD, VT and WY; and Internationally to: ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, EGYPT, GERMANY, UNITED KINGDOM, IRELAND, IRAQ, ISRAEL, JAMAICA, JAPAN, JORDAN, KORE |
| FDA record | Open on fda.gov |